Bipolar disorder — encompassing Bipolar I (manic episodes), Bipolar II (hypomanic and depressive episodes), and cyclothymia — affects approximately 2.4% of the global population and carries significant risk of functional impairment and suicide. Clinical trials in bipolar disorder address three distinct phases: acute mania, bipolar depression, and maintenance to prevent episode recurrence. Bipolar depression is the most clinically challenging phase and the subject of the most active current research, as many antidepressants carry a risk of inducing mania.
Active trials investigate cariprazine for bipolar depression and mixed features, lumateperone (approved for bipolar depression), novel glutamate modulators, CGRP antagonists for bipolar with migraine comorbidity, and lithium pharmacogenomics to identify which patients will be optimal responders. Digital phenotyping trials — using smartphone data to detect early episode signs — are a growing area of clinical research in bipolar monitoring.
Bipolar disorder trials typically separate mania and depression phases and often exclude patients with recent substance use disorder; the MADRS or YMRS scale determines severity at baseline.
Frequently Asked Questions — bipolar disorders Clinical Trials
How many clinical trials are currently recruiting for bipolar disorders?
ClinicalMetric currently tracks 1 actively recruiting clinical trials for bipolar disorders, sourced in real time from ClinicalTrials.gov. The total number of registered studies—including those not yet enrolling or in active follow-up—is 1. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for bipolar disorders?
bipolar disorders research spans multiple clinical trial phases. Phase 1 studies evaluate safety and dosing in small groups, Phase 2 studies assess preliminary efficacy in 100–300 participants, and Phase 3 trials compare the new treatment against the standard of care in 300–3,000+ patients. Phase 4 post-approval studies monitor long-term outcomes in real-world populations.
How do I find out if I qualify for a bipolar disorders clinical trial?
Eligibility criteria for bipolar disorders trials vary by study and typically specify age range, disease stage or severity, prior treatment history, and specific diagnostic or laboratory parameters. Each listing on ClinicalMetric links to the full protocol on ClinicalTrials.gov, where inclusion and exclusion criteria are documented. Contact the sponsoring site's research coordinator directly to confirm your eligibility—your treating physician or specialist can also help identify the most appropriate trial based on your medical history and current treatment status.
Top Sponsors
University of Aarhus 1 trial
Recruiting Clinical Trials
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional.
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Last Reviewed: April 2026 ·
Data Methodology