Bipolar I disorder

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 trial is testing the safety of a medication called lumateperone in children and teenagers who have schizophrenia, bipolar disorder, or autism spectrum disorder. Participants take the drug once daily for 26 weeks, and researchers monitor for side effects. The goal is to see i…

This expanded access program offers continued treatment with OLZ/SAM, a combination of olanzapine and samidorphan, to adolescents with schizophrenia or bipolar I disorder who have already completed a year-long study of the drug. The goal is to provide ongoing access to the medica…

This study tests whether deep brain stimulation (DBS) can safely treat severe, treatment-resistant bipolar depression. The approach uses a brain implant that delivers stimulation and simultaneously monitors brain signals linked to depression and mania. The goal is to see if this …

This trial tests whether two different eating plans—time-restricted eating (eating within a 10-hour window each day) and a Mediterranean diet—can help people with bipolar disorder. Participants will track their eating, sleep, and mood for two weeks, then follow one of the diets f…

This study tests whether the drug lumateperone can safely reduce symptoms of depression in children and teenagers (ages 10 to 17) with bipolar I or II disorder who are currently in a major depressive episode. Participants receive either lumateperone or a placebo daily for several…

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 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 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 tests whether adding a four-week aerobic exercise program to a new antipsychotic medication (olanzapine-samidorphan) can prevent the early weight gain often seen with these drugs. Thirty adults with schizophrenia, schizoaffective disorder, or bipolar disorder will take…

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 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 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 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 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 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 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 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 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 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 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 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 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 study tests a program called SUPPORT, where trained peer specialists (fellow veterans) help veterans with serious mental illness (like schizophrenia or bipolar disorder) who are at high risk for suicide. Together, they create a personalized recovery plan that includes coping…

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 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 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 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 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 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 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 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 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 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 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 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 investigates whether markers of inflammation in the blood could serve as diagnostic or severity biomarkers across several psychiatric conditions, including bipolar disorder, schizophrenia, and depressive episodes with psychotic features. Researchers will collect blood …

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 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 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 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 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 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…