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Condition Guide

New Treatments & Clinical Trials for Bipolar Disorder

Last updated August 2026Data from ClinicalTrials.gov252 active trials
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Bipolar disorder affects about 2.8% of U.S. adults and involves episodes of mania or hypomania alternating with depression. Current treatment typically combines mood stabilizers like lithium or valproate, atypical antipsychotics, and sometimes antidepressants. Many people find a regimen that prevents severe episodes, though finding the right combination can take time.

What's actually going on in research

Trials are testing new antipsychotics with fewer metabolic side effects, faster-acting drugs for acute mania and depression, and treatments targeting specific symptoms like mixed episodes or cognitive problems. Researchers are also studying ketamine and psilocybin for treatment-resistant bipolar depression, digital tools for tracking mood patterns, and biomarkers that might predict which medications will work for which patients.

Rapid-acting treatments

Ketamine and related drugs may lift bipolar depression within hours rather than weeks. Trials are testing whether they work safely in bipolar disorder, where antidepressants can trigger mania.

Metabolic-friendly antipsychotics

Newer antipsychotics aim to stabilize mood without the weight gain and diabetes risk of older drugs. Several are in late-stage testing for mania and maintenance treatment.

Digital monitoring

Apps and wearables that track sleep, activity, and mood may catch early warning signs of episodes. Studies are testing whether this real-time data helps people stay stable longer.

What to know before you search

Eligibility usually depends on bipolar type (I or II), current episode (manic, depressive, or mixed), recent medication history, and absence of substance use disorders or certain other conditions.

What types of trials are currently open

  • Acute mania trials — Testing medications to calm manic episodes, usually in hospital or closely monitored settings. Most compare a new drug to placebo or an existing antipsychotic.
  • Bipolar depression trials — Testing treatments for depressive episodes, including new antipsychotics, ketamine, and combinations. A major challenge is lifting depression without triggering mania.
  • Maintenance trials — Testing whether a drug prevents future episodes over months or years. Participants are usually stable when they enroll and stay on the drug long-term.
  • Mixed episode trials — Testing drugs for episodes with both manic and depressive symptoms at once, which are harder to treat than pure mania or depression.
  • Cognitive trials — Testing treatments for memory, attention, and executive function problems, which persist even when mood is stable.

Recently added Bipolar Disorder trials

RecruitingObservational study

Health Assessment in People With Severe Mental Illness

People living with severe mental illness (SMI) experience substantial physical health inequalities, including an increased prevalence of cardiovascular disease, obesity, metabolic disorders, reduced physical fitness, and premature mortality. Physical inactivity, prolonged sedentary behavior, sleep disturbances, and the metabolic effects of psychiatric medications may contribute to these health problems. The PHASMI study aims to provide a comprehensive assessment of physical health, cardiorespiratory fitness, cardiometabolic risk, physical functioning, lifestyle characteristics, emotional well-being, and health-related quality of life in adults with severe mental illness. The primary objective is to investigate associations between sociodemographic, clinical, and lifestyle characteristics and cardiorespiratory fitness, assessed through peak oxygen uptake (VO2peak). PHASMI is an observational, descriptive, cross-sectional study conducted in Álava, Spain. The anticipated sample comprises 275 adults aged 18 to 65 years with a diagnosis of severe mental illness according to DSM-5 criteria established by psychiatry specialists. Participants will be recruited through the Mental Health Network of Álava, including individuals receiving community-based psychiatric care and hospitalized patients. Participants will undergo a comprehensive health assessment involving cardiopulmonary exercise testing on a treadmill using a modified Bruce protocol, the Modified Shuttle Walk Test, anthropometric measurements, body composition analysis, blood pressure measurements, electrocardiography, laboratory analyses, handgrip strength testing, and standardized assessments of physical functioning. Physical activity, sedentary behavior, and sleep will be assessed using standardized questionnaires and a wrist-worn ActiGraph GT3X+ accelerometer over eight consecutive days. Emotional well-being and health-related quality of life will be evaluated using validated questionnaires. The main in-person assessments will be conducted over two consecutive days at the University of the Basque Country and the Psychiatric Hospital of Álava. Written informed consent will be obtained before participation. No experimental treatment or therapeutic intervention will be assigned. By examining associations between physical fitness, cardiometabolic health, lifestyle characteristics, and psychological well-being, PHASMI seeks to identify potentially modifiable factors associated with poorer physical health and inform future prevention and health promotion strategies for people living with severe mental illness.

Vitoria-Gasteiz, Alava, Spain
RecruitingInterventional study

Affective Cognitive Training in Mood Disorders and High-risk Relatives

The aim of this clinical trial is to investigate the effects of a six-week targeted affective cognitive training, combining virtual reality and computer-based exercises, in symptomatically stable patients with mood disorders (major depressive disorder or bipolar disorder) and unaffected first-degree relatives. The investigators hypothesize that targeted affective cognitive training, compared with treatment as usual, will improve affective cognition (primary outcome), assessed using a composite measure of emotion regulation and facial emotion recognition. Secondly, the investigators hypothesize that the training will improve self-reported emotion regulation abilities and associated neural activity during emotion regulation, including changes in dorsolateral prefrontal cortex activity. Finally, the investigators will explore whether the training affects broader cognitive functioning, psychosocial functioning, quality of life, and longer-term clinical outcomes, including relapse or onset of mood disorder.

Frederiksberg, Capital Region of Denmark, Denmark
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