BIPOLAR I DISORDER

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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…