Latest news with #bipolar
Yahoo
3 hours ago
- Health
- Yahoo
I Went To The ER. I Ended Up Handcuffed In The Back Of A Cop Car.
When I finally told someone I was afraid I might hurt myself, I thought I was doing what everyone says to do: 'Ask for help. Tell someone. Don't suffer in silence.' I didn't expect to end up handcuffed in the back of a police cruiser, stripped of my clothes, my rights, and any remaining dignity. I had been struggling. Sleep-deprived and in the throes of a bipolar mixed episode, physically wrecked by chronic illness, and stressed to the max. I didn't want to die, living had just become too painful. When I finally said it out loud, honestly and clearly to a psychiatrist in the ER, I wasn't in any immediate danger. I was asking for help early, while I still could. The plan was agreed on with the consulting psychiatrist: a voluntary admission to a reputable hospital with a decent psychiatric unit. We even made a list of hospitals I was OK with, and two I absolutely was not. I knew from personal experience as a peer support volunteer that one was poorly managed, unsafe and chaotic. The other was underfunded and more like a holding pen for people. I wasn't asking for five stars; I just wanted to avoid any more trauma. But when it came time to transfer me, none of the hospitals we had agreed to had a bed. Guess who did. I refused. Calmly, clearly. I offered to remain in the ER on suicide precautions until a bed opened elsewhere. I was told that was unreasonable because I was 'stable' and the ER is for emergencies. I asked to be discharged to go directly to another hospital, with my partner. I was told that would put me at risk of harm. I was in crisis, yes — but I was asking for help. I did not understand that by self-reporting that I was at risk, I had given away my control. Their solution was to issue a 72-hour Temporary Detention Order (TDO) and force me to go. Two police officers showed up. Quiet. Professional. Still cops. They took my clothes, my phone, my belongings and my autonomy. Strip search. Handcuffs. I was paraded through the hospital in front of patients and staff like I was being arrested ― because I told the truth about being in pain. I have no criminal history. The only time I've been inside a 'correctional' facility was as a peer support volunteer, working with others who were also detained against their will. But now I was being treated like something dangerous, just because I'd admitted I was vulnerable. What followed was one of the worst weeks of my life. The conditions in the psych unit were worse than anything I ever saw in jails. I was locked in my room nearly the entire time. No TV. No books. The food was inedible, and I barely ate. My bed was a wooden plank. My blanket? ONE hand towel. Two hand towels are apparently highly dangerous. I was not permitted to shower unobserved. Related: My roommate, deep in psychosis, spent most of the time arguing with ghosts and screaming at Jesus. He wasn't violent, just suffering. During his brief lucid moments, he was sweet and apologized profusely. It was heartbreaking. There was no therapy. No individual counseling. No structured treatment of any kind. There was an hour of crafts run by a warm and caring volunteer, which was one of the few times I was allowed out of my room. I wasn't consulted about my treatment plan or offered options or alternatives. Just crafts and lithium. Lithium can be incredibly effective for many people in crisis, but has a long list of side effects and risks. Also, in some cases — like mine ― it is simply ineffective. Which, if anyone had cared to listen to me, I could have told them. There is no better historian about me than me. At the conclusion of the 10 minutes I had with my doctor, he was annoyed that I had been TDO'ed there. He agreed that I was experiencing a crisis, but far from an urgent one, and definitely not worth being on his ward for psychotic and violent patients. He knew I didn't belong there, and he wanted me out as much as I did. He also didn't want to medicate me unnecessarily. But he knew how the judge operated. The bipolar TDO checklist was in play. If my lithium levels weren't in the therapeutic range, my clinical status wouldn't matter. Seventy-two hours would then become 30 days. So he said, gently: 'Just take it. Two days. It'll suck, but it's the only way out.' I was less than 24 hours in, and it was already unbearable. So, I agreed, reluctantly. My court-appointed lawyer showed up five minutes before the hearing, also trying to help. He advised me to surrender my Second Amendment rights, not because I posed any danger, but because the judge would require it. If I declined: 30 days. I didn't own a gun and have no intention of ever buying one. I'm something of a pacifist and abhor tools of violence. The lawyer explained that I could later apply to have my rights restored and that it was technically voluntary ... but it might still show up on legal forms, indefinitely. An administrative scarlet letter. A permanent mark from a temporary hold. Related: I reluctantly agreed. But the best time to make consequential legal decisions is NOT during involuntary detainment with only five minutes of legal counsel. And if I was too unwell to make medical decisions, how was I somehow competent enough to waive constitutional rights? If I was well enough to make those decisions, maybe I didn't belong there at all. The judge, barely looking at me or my file, asked if my lithium levels were therapeutic. He asked if I'd surrendered my gun rights. He checked the boxes on his list. He still extended the TDO to 30 days, but allowed a provision for my doctor to override it, which he immediately did. And just like that, I was discharged. No therapy. No plan. No follow-up. Just out. Still in crisis, but now disoriented, sick from the lithium, humiliated, and traumatized on top of it. I left worse than when I entered. Now, when things get bad, when I'm sleep-deprived, when my body isn't working right, when my thoughts start to splinter, I instinctively hesitate to tell anyone. Because now I know that honesty isn't always safe. What happened to me wasn't an outlier. It wasn't a rare failure inside a system that usually works. This IS how the system works. A system that responds to pain and suffering with containment instead of care. A system that substitutes police for therapists, and compliance for healing. So, I'm cautious. If I end up in crisis again, the ER is the last place I would turn. Not unless someone I trust can promise me that I won't be punished for trying to stay alive. That I won't be criminalized for being sick. That the words I say won't be used to take away my voice. I didn't end up in that facility by accident. I ended up there because I'm publicly insured, because I have a chronic illness, because I live in the wrong zip code and asked for the wrong kind of help on the wrong day of the week. Many people, especially those already marginalized, have no trusted provider, no family support, no safety net. And for people in that position, ERs are often the only option, but also the most expensive and the least likely to provide care. And if you're poor, disabled, incarcerated, uninsured, a person of color, an immigrant, identify as a woman or LGBT+, or as part of any marginalized group? The chances that you'll receive actual care drop even further. Yet my story is not a message to stay silent, or to avoid seeking help. It's a message to demand better helpn— and to ask for it in ways that protect your dignity. Start with someone you trust. A partner, a close friend, a spiritual adviser. Someone who truly cares and can walk with you, literally or figuratively. If you have an established relationship with a family doctor or a mental health professional, built on trust, start there. Ask them to help you navigate, to advocate, to hold space. Don't be afraid to ask how providers handle mental health emergencies. Tell your loved ones and providers your wishes if you are ever in crisis. Create a 'Psychiatric Advance Directive.' Put your wishes in writing. Identify who should speak for you, what medications you will or won't accept, what facilities are off-limits. A crisis is not the time to start setting boundaries. Do it now. There are some organizations doing it differently. If you're struggling, The Trevor Project offers 24/7 crisis support and can help you figure out the safest route forward. Or try searching for 'crisis warm lines.' These are peer-run resources — people who've been there, who can help you figure out where to start. No judgment. No police. I can't promise that your experience will be better than mine. But I can say this: You deserve for it to be. We all do. If you or someone you know needs help, call or text 988 or chat for mental health support. Additionally, you can find local mental health and crisis resources at Outside of the U.S., please visit the International Association for Suicide Prevention. This article originally appeared on HuffPost in June 2025. Also in Goodful: Also in Goodful: Also in Goodful: Solve the daily Crossword
Daily Mail
02-08-2025
- Health
- Daily Mail
Heston Blumenthal reveals he's taking weight-loss drug Wegovy and shares fears that slimming jabs could pose a threat to the food industry
Heston Blumenthal has revealed he's taking the weight-loss drug Wegovy. The celebrity chef, 59, told how he's been taking the slimming aid to help combat the effects of his bipolar medication, having been diagnosed with type 1 bipolar in 2023. Heston also expressed his fears that the rise in popularity of weight loss jabs could pose a threat to the food industry. Speaking to Times Radio, Heston explained: 'I've put on so much weight, but it's starting to come off now', before adding that his use of the drug is a 'paradox' given the fact he's a restaurateur. The TV personality remarked how he'd lost 'eight kilos' on Wegovy so far, however, he has also dealt with side effects including brain fog, slurred speech and problems with balance. The drugs contain semaglutide, an amino acid, which suppresses appetite by mimicking a hormone telling the brain you are full up. In a new interview, the celebrity chef, 59, told how he's been taking the slimming aid to help combat the effects of his bipolar medication, having been diagnosed with type 1 bipolar back in 2023 [Boxes of Wegovy pictured] Heston issued a warning to the food industry, remarking how the continued use of the popular slimming jabs could have a detrimental affect on it. He explained: 'Wegovy, Ozempic, Mounjaro – you still enjoy food, but it stops appetite, so what's going to happen is people are going to want smaller portions.' Heston added that things were 'going to get much worse in the next six months' for restaurants, before expressing that supermarkets would also be affected. However, the food writer noted that he's 'formulating a plan' in a bid to help the food industry. Elsewhere, last month, Heston revealed he 'had thought about different ways of ending [his life]' before eventually receiving treatment for bipolar disorder. The London-born celebrity chef, who holds a total of seven Michelin stars across his restaurants, was diagnosed with type 1 bipolar after being sectioned - on the insistence of his wife, French entrepreneur Melanie Ceysson - in November 2023. Bipolar disorder is a brain disorder which causes unusual and often sudden changes in mood and energy levels. He spent two weeks heavily medicated in a psychiatric hospital and a further six weeks in a clinic, where he continued with intensive treatment and practised walking meditation. Yet, four years previously, he had already hit rock bottom and was contemplating the method he would use to take his own life. Looking back to filming the cookery show Crazy Delicious in 2019, Heston told The Times: 'I remember lying on the sofa the night before I was due to go to do the show - I didn't want to do it, because of the condition I was in - and I had thought about different ways of finishing [my life]. 'I went through a list: knife? No, can't do that. Gun? Don't have one. Rope? I don't think I could do that; wouldn't know how. It would probably slip off or whatever. 'And there was no train station anywhere near to jump in front of a train.' The father-of-four, whose first eatery, The Fat Duck, was named the best restaurant in the world in 2005, added that he didn't perceive that he was in a depressive state - even when he 'was talking about suicide or death'. He told the publication: 'I must have been in a mixed state [a period of rapid highs and lows], because I was excited about planning my funeral, planning my wake. What music I wanted, who I wanted there - I got quite excited about that.'
Yahoo
01-08-2025
- Business
- Yahoo
BioXcel Therapeutics Announces Last Patient Last Visit in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
Vast majority of patients dosed completed the full 12-week study Data from more than 2,200 agitation episodes collected Topline data readout anticipated this month NEW HAVEN, Conn., Aug. 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced completion of the last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial. Topline data from the study are expected to be released this month and are intended to support the planned supplemental New Drug Application (sNDA) to potentially expand the label of IGALMI® (dexmedetomidine) for use in the at-home (outpatient) setting. The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The SERENITY At-Home study enrolled more than 200 patients across 22 sites nationwide, with no single site enrolling more than 11% of the total patient population. Distribution of patients was balanced between the two patient populations, bipolar disorders and schizophrenia. 'This marks a major milestone in our efforts to bring a much-needed at-home (outpatient) treatment option to the millions of individuals who experience agitation related to bipolar disorders or schizophrenia,' said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. 'We're grateful to the patients, caregivers, investigators, CRO, and our internal teams who made this possible in a very timely manner. With this final visit complete, we look forward to sharing topline results soon. This is another critical step toward advancing BXCL501 (IGALMI®) as the first FDA-approved therapy for this indication in the home setting.' There are an estimated 23 million episodes of bipolar or schizophrenia-related agitation annually in the U.S. that occur at home 1-3, and there are currently no FDA-approved therapies for acute treatment in this setting. About the SERENITY At-Home Phase 3 Trial The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients are self-administering 120 mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. In addition, patients or caregivers/informants will complete a modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting. About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer's dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About IGALMI® (dexmedetomidine) sublingual film INDICATION IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or medinfo@ Please see full prescribing information at About BioXcel Therapeutics, Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company's drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit Forward-Looking Statements This current report includes 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this current report other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company's upcoming data release and sNDA submission. When used herein, words including 'anticipate,' 'believe,' 'can,' 'continue,' 'could,' 'designed,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including the factors discussed under the caption 'Risk Factors' in its most recent Quarterly Report on Form 10-Q, as such factors may be updated from time to time in its other filings with the SEC. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this current report. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this current report. Contact Information Corporate/Investors Russo Partners Nic Johnson 1.303.482.6405 Media Russo Partners David Schull 1.858.717.2310 Source: BioXcel Therapeutics, Inc. IGALMI® is a registered trademark of BioXcel Therapeutics, Inc. References Data on file relating to agitation episodes associated with schizophrenia or bipolar I or II disorder. BioXcel Therapeutics, Inc. New Haven, CT December 2020. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller. Data from Wu EQ, Shi L, Birnbaum H, et al. Annual prevalence of diagnosed schizophrenia in the USA: a claims data analysis approach. Psychol Med. 2006;36(11):1535-1540. Estimates based on whether indications are approved for at-home use for the intended patient population and such patients are treatable. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller. National Institute of Mental Health. Prevalence of bipolar disorder in adults. November 2017. Accessed December 16, 2022. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
01-07-2025
- Business
- Yahoo
BioXcel Therapeutics Receives Second Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
DSMB recommended the continuation of trial as planned Topline data expected in Q3 2025 NEW HAVEN, Conn., July 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without modification, the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia. The DSMB recommendation followed a review of unblinded safety data from 178 patients dosed as of the May 28, 2025 cutoff date. The trial is fully enrolled and collection of data over the 12-week period is continuing. 'We are pleased with this additional favorable recommendation from the DSMB regarding our first at-home trial of BXCL501 and look forward to the upcoming data readout,' said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. 'Bipolar and schizophrenia-related agitation in the at-home setting is a large, unmet medical need, with no FDA-approved therapies. We are highly motivated to address this need for millions of patients, with trial data intended to support a potential sNDA submission to expand the IGALMI® label in the at-home setting.' The SERENITY At-Home Phase 3 trial is designed as a double-blind, placebo-controlled study to evaluate the safety of a 120 mcg dose of BXCL501 in 200 patients for acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. Trial enrollment was completed in May, 2025 Topline data expected in Q3 2025. Additional information on the SERENITY At-Home trial is included in a corporate presentation in the Investors section of the Company's website: About BXCL501Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer's dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About the SERENITY At-Home Phase 3 TrialThe SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients are self-administering 120 mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. In addition, patients or caregivers/informants will complete a modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as exploratory endpoints to evaluate use in the outpatient setting. About IGALMI® (dexmedetomidine) sublingual film INDICATION IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or medinfo@ Please see full prescribing information at About BioXcel Therapeutics, Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company's drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit Forward-Looking Statements This press release includes 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company's planned advancement of its SERENITY trial; potential market opportunity for BXCL501; completing enrollment and release of topline data from the ongoing SERENITY trial; submission of an sNDA; expanding the IGALMI® label in the at-home setting; the potential for the results from the Company's completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidates. When used herein, words including 'anticipate,' 'believe,' 'can,' 'continue,' 'could,' 'designed,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company's total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company's product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company's product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care 'fraud and abuse' laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption 'Risk Factors' in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC's website at and the Investors section of the Company's website at These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release. Contact Information InvestorsRusso PartnersNic Johnson1.303.482.6405 MediaRusso PartnersDavid Schull1.858.717.2310 Source: BioXcel Therapeutics, is a registered trademark of BioXcel Therapeutics, in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
BBC News
20-06-2025
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Bereaved Clacton mum praises Blumenthal for bipolar film
A bereaved mother who took part in Heston Blumenthal's documentary about bipolar disorder has praised the "super brave" celebrity chef for wanting to end the stigma on mental opened up about his illness and spoke to others about their experience for the BBC film, My Life with them was Natalie McClellan, whose 24-year-old daughter Rebecca had bipolar and died in Ipswich in November 2023."If Heston can say 'I have bipolar but look at what I'm achieving, you can live a fulfilling life', it might change perspectives on mental illness," said Ms McClellan. "He is super brave to do it; he has really put himself out there to help others."I try to do the same, but none of its easy."Since Rebecca's death, Ms McClellan has campaigned for improved mental health provision that could have helped her daughter, who she said felt "abandoned". She shared her story with Blumenthal over several hours at her home in Clacton-on Sea, emotional experience helped them both, she said, particularly as Rebecca and Blumenthal had much in even transpired that he had gone into hospital for his condition when Rebecca died."They had the same sorts of visual disturbances, he's got ADHD and she was awaiting a diagnosis," she said."I showed him videos of her, photos, and one video in particular where she says 'my bipolar is popping'."He said 'that's exactly how it is', I think he found that emotional." The chef also became upset when talking about the impact of his bipolar disorder on his family - an experience that rang true for Ms McClellan."Rebecca didn't always tell us [how she felt], she would mask because she was worried about the effect it would have on us," she said."You just want your loved ones to be well and know what's going on, obviously I would rather worry every day but still have her here."Heston was quite open, he feels he has hurt his family and she [Rebecca] would be the same." The trainee paramedic was left with no GP or psychiatrist when she moved to Ipswich for work, her mother previously told the August 2023, she drove to a mental health unit and begged for help and said she was willing to drive anywhere in Norfolk and Suffolk to see someone, but staff told her to leave and threatened to call police. 'Not complacent' In the film, Blumenthal is shown Rebecca's mobile footage of the incident, which he described as "absolutely shocking"."Since we lost Bex it's been really important for me to push for changes in mental health and the support people get," added Ms McClellan."I will keep going and keep going for people who are suffering in the way she suffered, but it's not easy, it's only been 18 months [since her death] and it's still very raw."The reason Heston was speaking out was he wants to end the stigma. "It's so important to me that I'm part of that message."I was honoured and proud to be part of that process, and I hope he feels proud, too."Rebecca was under the care of the Norfolk and Suffolk NHS Foundation Trust (NSFT), which was in special measures for several years until January this March it completed a review into the circumstances of her death. A date for an inquest has not been chief Caroline Donovan, who joined in autumn 2023, said it had made "considerable progress" in its work to learn from deaths of patients and thanked Ms McClellan and other families for their "invaluable challenge and support"."We are not complacent and know we have much more to do to transform our services so that everyone receives safer, kinder and better services from us when they need them," she My Life with Bipolar is available on BBC iplayerIf you are affected by any of the issues in this article you can find details of organisations that can help via BBC Action Line. Follow Suffolk news on BBC Sounds, Facebook, Instagram and X.
