Bipolar I disorder

This Phase 3 study tests whether KarXT, a combination of two drugs, can safely reduce manic symptoms in people with Bipolar-I disorder. About 274 participants hospitalized for mania will receive either KarXT or a placebo. The main goal is to see if KarXT improves scores on a stan…

This study tests whether adding KarXT to standard mood stabilizers (lithium, valproate, or lamotrigine) helps control manic episodes in people with bipolar I disorder. About 424 adults hospitalized for mania will receive either KarXT or a placebo for 5 weeks. The main goal is to …

This phase 3 study is testing the long-term safety of KarXT, a new drug for managing mania in people with bipolar I disorder. About 450 participants, including those who completed earlier studies and new volunteers, will take KarXT along with standard mood stabilizers like lithiu…

This study will enroll 1,000 adults with both opioid use disorder and a mental health condition. Participants will receive standard medication for opioid use disorder, with some also getting a team-based support program called MISSION. The goal is to see if MISSION helps people s…

This study tests whether a combination drug called OLZ/SAM (olanzapine plus samidorphan) causes less weight gain than olanzapine alone in teenagers with schizophrenia or bipolar I disorder. About 220 teens aged 10-17 will take either the combo or olanzapine for 52 weeks. The main…

This study compares clozapine and risperidone in people with schizophrenia, schizoaffective disorder, or bipolar I disorder with psychosis. Researchers want to see if a specific brain biotype (Biotype-1) responds better to clozapine. About 320 participants will be randomly assign…

This study tests a program called Tunawiri (meaning 'thrive') that adds mental health screening, counseling, and support to regular HIV care for pregnant and postpartum women in Kenya. The goal is to improve depression, anxiety, and HIV treatment success. Nine hundred women will …

This study tests a long-acting injection of cariprazine given once a month, instead of daily pills, for people with schizophrenia, bipolar I disorder, or major depression. The trial involves 24 clinically stable adults and will check safety, side effects, and how well the drug wo…

This study tests a gamified mobile health app designed to reduce suicide risk in adults with mental disorders after they leave the hospital. Researchers will enroll 640 participants in Shenzhen, China, and use game-like features to encourage treatment adherence and follow-up visi…

This study tests whether a 16-week ketogenic diet (low carbs, high fat, medium protein) can help teens aged 12–21 with bipolar disorder. Eighty participants will receive the diet plus standard medication, with coaching from dietitians and monthly checkups. Researchers will track …

This study compares a new crystallized lithium (AL001) to standard lithium carbonate in 20 people with bipolar I disorder. Participants take each drug for 14 days and undergo MRIs and blood tests to measure how lithium enters the brain and body. The goal is to see if AL001 is saf…

This study tests whether matching specific weight-loss medications (Wegovy, Contrave, or Qsymia) to a person's obesity type (e.g., 'hungry brain' or 'emotional hunger') helps people with bipolar disorder lose weight safely. One hundred adults with bipolar or schizoaffective disor…

This study tests whether a non-invasive brain stimulation technique called TMS can help people with mental illness quit smoking. Forty daily smokers with psychiatric conditions will receive either TMS or standard care. The goal is to see if TMS is practical and effective in real-…

This study tests whether a six-month program of dietary counseling and group exercise can reduce heart disease risk in adults with severe mental illnesses like schizophrenia or bipolar disorder. Around 70 participants will either receive the lifestyle program plus usual care, or …

This study tests whether yoga-based exercises can help veterans with schizophrenia, schizoaffective disorder, or bipolar 1 disorder improve their ability to function in daily life—like socializing, working, and managing leisure activities. About 112 veterans will be randomly assi…

This study tests whether cariprazine (Vraylar) can safely ease depressive episodes in teens aged 10-17 with bipolar I disorder. Around 380 participants will receive either the drug or a placebo for 6 weeks, with dose adjustments based on response. The goal is to see if the drug i…

This study tests whether adding magnesium vitamin B6 to usual treatment can reduce depression, anxiety, and stress in people experiencing their first episode of bipolar I disorder. Forty adults aged 18-50 will take either the supplement or a placebo three times daily for four wee…

This study tests an experimental drug called RAP-219 for people with bipolar I disorder who are currently experiencing a manic episode. About 250 participants will receive either RAP-219 or a placebo daily for 21 days. Researchers will measure changes in manic symptoms using a st…

This study is testing the safety and tolerability of an experimental drug called ABBV-932 for people with bipolar I or II disorder who are currently in a depressive episode. About 200 adults will take the drug as capsules for 26 weeks, with regular check-ups and tests to monitor …

This study tests a program called SKILLS that focuses on common factors across different mental health conditions, rather than treating each disorder separately. About 60 adults with stable psychiatric diagnoses will take part. The goal is to see if this approach reduces symptoms…

This study tests whether the drug KarXT can reduce symptoms of mania in people with Bipolar I disorder who are currently hospitalized for a manic episode. About 274 participants will receive either KarXT or a placebo for 3 weeks while staying in the hospital. The main goal is to …

This Phase 3 trial tests whether a daily pill called azetukalner can safely reduce depression in people with bipolar I or II disorder. About 400 adults currently in a depressive episode will take either the drug or a placebo for 6 weeks. Researchers will measure mood changes usin…

This study tests a telemedicine-delivered cognitive behavioral program (RxWell) to help adults with anxiety or depression use fewer opioids after knee or hip replacement. About 150 participants will be enrolled. The program aims to improve mood and reduce painkiller use by provid…

This study tests an experimental drug called icalcaprant for treating depression in people with bipolar I or II disorder. About 195 adults will take either the drug or a placebo daily for 6 weeks. Researchers will measure changes in depression symptoms and watch for side effects.

This Phase 2 study tests whether LB-102 can reduce depressive symptoms in adults with bipolar I disorder who are currently in a major depressive episode. About 320 participants will receive either the drug or a placebo for 6 weeks. The main goal is to see if LB-102 improves depre…

This pilot study tests whether time-restricted eating (eating all food within a 10-hour window each day) is feasible and acceptable for people with bipolar disorder. 40 participants will either follow the eating schedule or receive nutritional counseling for 8 weeks. The goal is …

This study tests a program called SUPERCEDE, which provides intensive case management to veterans who are at risk for suicide and receive care both from the VA and outside community providers. The goal is to improve care coordination, reduce suicidal thoughts, and improve daily f…

This early-stage trial tests BXCL501, a dissolving film placed under the tongue, to quickly reduce agitation in children and teens aged 10-17 with schizophrenia or bipolar disorder. About 140 participants will receive either the drug or a placebo. The study measures changes in ag…

This pilot study tests whether adding ear acupressure (small seeds taped to ear points) to standard nicotine patches or gum can reduce cravings, withdrawal symptoms, and anxiety in psychiatric inpatients who must stop smoking during their hospital stay. Sixty participants will be…

This study is testing whether a virtual reality version of a therapy exercise is practical and helpful for adults (ages 18-65) with psychiatric disorders. Participants will try one VR session and answer questions about their experience. The goal is to see if this approach is acce…

This study tests an AI chatbot called Aurora that guides people through creating a personal life story to improve emotional well-being and identity. It includes healthy adults, adults with mental health conditions in residential care, and older adults aged 65+. The chatbot is not…

This study tests an experimental drug called NBI-1117568 for adults with bipolar I disorder who are hospitalized for a manic episode. Half of the 150 participants will get the drug, half a placebo, to see if it safely reduces manic symptoms over 21 days. The goal is to find a new…

This study is testing a type of talk therapy called Emotion Regulation Therapy (ERT) delivered over video for people in New York who struggle with worry, overthinking, or being hard on themselves. The goal is to see if the therapy helps people better manage their emotions and fee…

This early-stage study at Yale is testing whether a single 25 mg dose of psilocybin is safe and tolerable for people whose daily life is impaired by mood, anxiety, trauma, or addiction symptoms. Fifty participants will receive the drug openly (everyone knows they get it) and be f…

This study tests a smartphone app called mSITE that encourages people with schizophrenia or schizoaffective disorder to have more social interactions. Researchers will track participants' social activity and symptoms over time. The goal is to see if the app helps reduce social wi…

This phase 3 trial tests whether adding lacosamide to standard treatment helps people with bipolar disorder who are currently in a major depressive episode. Forty adults who haven't responded to at least two prior treatments will receive either lacosamide or a placebo for 12 week…

This study looks at how well and how safely a new sleep medication, lemborexant, works for people who have both a mental health condition and trouble sleeping. About 121 adults will take the drug for 8 weeks, and researchers will track changes in their sleep quality and any side …

This study looks at whether watching Netflix or Disney shows in a small group for 90 minutes each week, over 6 weeks, can improve emotional awareness and reduce anxiety and depression. About 70 adults who have been in mental health treatment for at least 6 months will take part. …

This study tests a multi-sensory therapy called Heal, which uses calming sounds, gentle vibrations, and soft lighting to help detained youth (ages 12-18) manage their emotions before counseling sessions. The goal is to see if this brief, non-verbal intervention improves emotional…

This study tests a program called 'Need to Be Needed' (N2BN) that uses volunteering to help adults with serious mental illness feel more connected and less lonely. 120 participants will either join the volunteering program or receive weekly listening support. Researchers will mea…

This study tests whether sailing can help people with psychiatric disorders feel better. Forty adults in France will either take sailing lessons or continue their usual care. Researchers will measure changes in quality of life, mental well-being, and self-esteem to see if sailing…

This study looks at whether eating only during certain hours of the day (time-restricted eating) can help people with bipolar disorder feel better. About 150 adults who are already on medication for bipolar disorder will track their eating, sleep, and mood for 2 weeks, then follo…

This study tests whether a ketogenic diet (high fat, low carb) can improve brain energy and reduce psychiatric symptoms in people with early bipolar disorder. Fifty participants will follow either the ketogenic diet or standard dietary guidelines for 12 weeks. Researchers will me…

This study is testing a new social skills training program for Veterans with serious mental illness (like schizophrenia, bipolar disorder, or PTSD) who are looking for work. The program teaches skills to better understand social cues and handle workplace relationships. Researcher…

This study tests whether bezafibrate, a drug currently used for high cholesterol, can safely improve depression in people with bipolar disorder. Thirty adults with bipolar I or II who are already on a mood-stabilizing medication will take bezafibrate for 8 weeks. Researchers will…

This study tests whether wearing blue-blocking glasses can reduce manic symptoms in people with bipolar 1 disorder during a manic episode. Twenty-five hospitalized adults will wear the glasses for 7 days. Researchers will check if the glasses are easy to use and if they help impr…

This study at the National Institute of Mental Health screens up to 16,000 people with mood or anxiety disorders, as well as healthy volunteers, to see if they can join other research studies. Participants undergo evaluations like psychiatric interviews, brain scans, and lab test…

This study looks at how tiny changes in your RNA (a molecule that reads your DNA) might help predict whether depression treatments will work. Researchers will follow 120 adults with unipolar or bipolar depression to see if these RNA changes match up with improvements in mood. The…

This study looks at how physical activity, sleep, and light exposure relate to mood in people with bipolar disorder, major depression, or no mood disorder. Over two years, participants wear activity monitors and complete smartphone diaries for up to 20 days at a time. The goal is…

This study compares two ways to help adults with mental health issues get follow-up care. One group gets usual care after an emergency room visit, while the other uses a new system that books a psychiatrist appointment within 48 hours through their general doctor. Researchers wil…

This study looks at whether a tool called the Decision Helper helps people with mental health conditions take a more active role in choosing their treatment. About 62 adults in Danish outpatient mental health clinics will have their consultations recorded and analyzed. The goal i…

This study looks at the mental health of 200 teenagers aged 12 to 16 who attend special educational institutes (ITEPs) in France. Researchers will use psychiatric interviews to find out how many have conditions like depression or anxiety. The goal is to better understand their ne…

This study aims to improve suicide prevention for people who move between healthcare and the criminal-legal system. Researchers will link health records, Medicaid data, and jail booking information to identify individuals at risk and coordinate care. Over 1,000 adults with past p…

This study is testing a new way to help families decide if their children should be screened for early signs of mental health problems. The children are ages 7 to 21 and have a parent with bipolar disorder. The researchers are creating a video and FAQ to help parents understand t…

This study looks at how feeling lonely and being socially isolated affect the brain and daily life in people with serious mental illnesses like psychosis or schizophrenia. Researchers will use surveys, daily diaries, and brain scans to understand these connections. The goal is to…

This study tests whether smartphone location data can give early warning of mood episodes (mania or depression) and drops in social activity for 200 veterans with bipolar disorder. Participants use an app that tracks their phone's GPS, and researchers will build computer algorith…

This study looks at why people with mood disorders may be at risk for suicide. Researchers will collect blood, urine, and survey answers from 300 participants to find patterns and build a model that predicts suicide risk. The goal is to better understand the factors involved so d…

This study uses brain scans (fMRI) to understand why people with bipolar disorder experience unstable moods compared to healthy individuals. Researchers will ask 72 participants to recall personal memories and practice boosting positive feelings while their brain activity is reco…

This study looks at how two types of energy—glucose and ketones—change brain activity and behavior in people with bipolar disorder. Participants will have MRI scans while playing money-winning games, before and after drinking either glucose or ketones. Researchers will compare re…

People with serious mental illness often have undiagnosed physical conditions like heart disease, diabetes, and cancer. This study tests whether adding routine physical health checks to psychiatric care helps find and treat these hidden illnesses. About 2,800 adults in Denmark wi…

This study explores whether a non-invasive magnetic brain stimulation technique (TMS) can temporarily improve how quickly people with psychotic disorders (like schizophrenia or bipolar) solve problems. About 95 participants will do thinking tasks and get brain scans before and af…

This study looks at whether a program with a nurse case manager can help people leaving prison visit a doctor or clinic instead of the emergency room. About 488 adults with a history of substance use and a chronic health condition will take part. Some will get extra support from …

This study looks at 320 people with early psychosis to see if brain scans, eye-tracking, and electrical brain waves can predict how well they respond to treatment. Participants will have four visits over a year, including interviews, memory tests, and optional DNA samples. The go…

This study tests whether using a life history calendar—a simple grid that helps people recall important life events—can improve the accuracy of mental health surveys. Researchers in Hong Kong will ask 2,500 adults about their mental health using either a standard interview or one…

This study tests whether combining a one-time session of brain stimulation (rTMS or electrical scalp stimulation) with emotion regulation training helps people with mood, anxiety, or related disorders better control their emotions. 240 participants will learn either cognitive res…

This study tests whether a special eye-tracking device (Gaize) can identify changes in eye movement patterns caused by long-term use of psychiatric medications. Researchers will observe 50 adults with conditions like ADHD, depression, or anxiety who have been on medication for ov…

This study follows 80 youth aged 9 to 19 with bipolar disorder across four U.S. sites. Researchers will track mood symptoms, inflammation, and family conflict over 12 months to find what predicts better or worse outcomes. The goal is to create standardized tools and best-practice…

This study looks at whether a recovery-focused program can help people with severe mental illness living in supported housing. About 72 participants will either receive the new program or standard care. The goal is to see if focusing on personal goals improves daily functioning a…

This study uses eye-tracking technology to measure how people with bipolar disorder pay attention, respond to rewards, and control their thoughts. Researchers will compare different groups, including those with anxiety or substance use issues. The goal is to better understand the…

This study is creating a program called START-VET to help veterans with mental illness or substance use disorders who have recently left prison. Researchers will work with 20 veterans to develop transition materials and tools. The goal is to improve quality of life and reduce cri…

This observational study follows 300 adults receiving strategic psychotherapy—a short-term, goal-focused talk therapy—in private practice. Participants fill out questionnaires about their symptoms and well-being before and after treatment. The goal is to see if this therapy leads…

This pilot study is testing whether a simple saliva test can help doctors prescribe mental health medications more safely and effectively. 200 adults in Manitoba who are starting or changing psychiatric drugs will provide a DNA sample. The results will be shared with their doctor…

This study looks at whether training psychiatric care teams to talk about sexual health with young patients (ages 15 and up) increases those conversations. Researchers will survey 770 teens hospitalized for psychiatric disorders about their sexual health and any side effects from…