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Home › Conditions › Bipolar Disorder

Bipolar Disorder

Subtypes of Bipolar Disorder

Bipolar I Disorder 3

34 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Bipolar Disorder

229 trials tracked for Bipolar Disorder: 114 in phase 3 or 4 and 30 with published results. The most-cited published study has 176 citations.

229Trials tracked
114Phase 3 & 4
0Recruiting
30With published results
Phase distribution
Phase 4 67 Phase 3 47 Phase 2 29 Phase 1 3 Other / NA 83
  1. Phase 3 Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial Completed · 176 cited
  2. Phase 3 12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017) Completed · 89 cited
  3. Phase 3 Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder Completed · 85 cited
  4. Phase 4 Metabolic Effects of Antipsychotics in Children Completed · 78 cited
  5. Phase 4 Acute Psychotherapy for Bipolar II Depression Completed · 67 cited
  6. Phase 3 Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Completed · 62 cited
Show 44 more trials
  1. Phase 4 Antidepressant Therapy in Treating Bipolar Type II Major Depression Completed · 53 cited
  2. Phase 3 Safety and Efficacy of Cariprazine for Mania Completed · 40 cited
  3. Phase 4 Treatment of Bipolar Mania in Older Adults Completed · 37 cited
  4. Phase 4 Citicoline for Bipolar 1 Disorder and Cocaine Dependence Completed · 36 cited
  5. Phase 3 Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder Completed · 29 cited
  6. Phase 3 Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression Completed · 29 cited
  7. Phase 4 Allopurinol Add-on Treatment for Refractory Mania Completed · 28 cited
  8. Phase 3 Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram Completed · 26 cited
  9. Phase 3 Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders Completed · 24 cited
  10. Phase 4 Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD) Completed · 22 cited
  11. Phase 4 Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI Completed · 16 cited
  12. Phase 3 A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder Completed · 14 cited
  13. Phase 4 CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL) Completed · 12 cited
  14. Phase 3 A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes Completed · 11 cited
  15. Phase 4 Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging Completed · 8 cited
  16. Phase 4 Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode Completed · 6 cited
  17. Phase 4 Cost- Effectiveness and Quality of Life Assessment in Mood Disorder Completed · 6 cited
  18. Phase 4 Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania Completed · 6 cited
  19. Phase 4 Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs Completed · 6 cited
  20. Phase 4 Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders Completed · 5 cited
  21. Phase 3 Lamotrigine Phase III Study in Bipolar I Disorder Completed · 5 cited
  22. Phase 4 Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients Completed · 2 cited
  23. Phase 3 Long-term Study of FK949E in Elderly Bipolar Disorder Patients Completed · 2 cited
  24. Phase 3 Treatment of Mania Symptoms With Drug Therapy Completed
  25. Phase 4 Study Using Pregnenolone to Treat Bipolar Depression Completed
  26. Phase 4 Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia Completed
  27. Phase 4 NMDA Antagonists in Bipolar Depression Completed
  28. Phase 4 FMRI Study of Brain Response Before and After Lithium Treatment in People With Bipolar Disorder Completed
  29. Phase 4 Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder Completed
  30. Phase 4 Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder Completed
  31. Phase 4 An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder Completed
  32. Phase 4 Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder Completed
  33. Phase 4 Memantine and Cognitive Dysfunction in Bipolar Disorder Completed
  34. Phase 4 Geodon in Weight Loss Study for Bipolar Disorders Completed
  35. Phase 4 Short Term Rescue Study of Olanzapine Completed
  36. Phase 4 Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults Completed
  37. Phase 4 Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder? Completed
  38. Phase 4 Iloperidone in Mixed States of Bipolar Disorder Completed
  39. Phase 4 Acamprosate vs. Placebo in Bipolar Alcoholics Completed
  40. Phase 4 Treatment of Alcohol Dependence and Comorbid Bipolar Disorder Completed
  41. Phase 4 Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine Completed
  42. Phase 4 Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder Completed
  43. Phase 4 Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes Completed
  44. Phase 4 Targeting Cognition in Bipolar Disorder With Pramipexole Completed

Showing the 50 most-cited and recently-updated of 229 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Bipolar Disorder: what the trials found

Valbenazine demonstrated a reduction in Tardive Dyskinesia Impact Scale (TDIS) total scores at week 24 1, while sublingual Igalmi was associated with significant reductions across multiple dimensions of the Positive and Negative Syndrome Scale- Excited Component (PEC) 2. Abilify Maintena showed statistically significant improvements in both the Brief Psychiatric Rating Scale (BPRS) and the Tablets Routine Questionnaire (TRQ) for both one-week and one-month assessments 17.

Lithium was evaluated across multiple trials, showing consistent sedation scores and a reduction in Young Mania Rating Scale (YMRS) scores 12, as well as specific Quality of Life Instrument scores 20. Metformin demonstrated significant reductions in BMI Z-scores at both 6 months and 24 months 19. Other established pharmacological interventions include risperidone, which showed changes in DEXA % body fat 9; venlafaxine 11; ziprasidone 15; fluoxetine 18; and quetiapine, the latter of which was associated with a reduction in the percentage of days of cannabis use per week 22.

Interpersonal and Social Rhythm Therapy (IPSRT) plus placebo showed significant improvement in remission rates compared to placebo 10, though results for Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) were not statistically significant 10. Other interventions established in the literature include CARE [7, 8], allopurinol 14, and citicoline 13.

Recent results — preliminary, needs further review

  • BE-SMART-DR showed significant improvements in suicidal ideation/propensity (SI/P) across both CHRT-SR and SSI scales, as well as significant changes in daily rhythms via the BSRS 3.
  • TMS was associated with significant improvements in reaction times during both negative and positive interference trials, though results for the Emotion Conflict Resolution Task were not statistically significant 4.
  • CRAFT-EP showed significant improvements in family wellbeing regarding depression and anxiety, but did not reach statistical significance for relationship scores 6.
  • CBTpro was associated with mean scores of 12.1 to 11.1 on the Revised Green Paranoid Thoughts Scale (R-GPTS) and a mean change in Sheehan Disability Scale (SDS) scores 5.

For the clinician treating this condition

  • Valbenazine and Igalmi show evidence of efficacy in reducing movement disorders and specific syndrome scales, respectively [1, 2].
  • Abilify Maintena is associated with significant improvements in psychiatric symptoms and medication adherence metrics 17.
  • Metformin has been shown to effectively reduce BMI Z-scores in patients with this condition 19.
  • Behavioral and rhythmic interventions like BE-SMART-DR show promise in reducing suicidal ideation and stabilizing daily rhythms 3.

AI synthesis of 18 cited trials, updated Jun 24, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Mental health syndemics reduce ART adherence and impair viral suppression in people living with HIV
Nephrology Meta-analysis
Mental health syndemics reduce ART adherence and impair viral suppression in people living with HIV When HIV and Depression Collide, Treatment Suffers
This systematic review and meta-analysis of 32 studies involving people living with HIV (PLWH) examined the impact of mental health-related …
When depression, trauma, and poverty pile onto HIV, people struggle more to take their meds and keep the virus in check.
Frontiers Apr 13, 2026
Hypoxia-cognition training showed no significant effects on prefrontal or hippocampal microstructure in remitted mood disorder patients
Neurology RCT
Hypoxia-cognition training showed no significant effects on prefrontal or hippocampal microstructure in remitted mood disorder patients Hypoxia training did not change brain scans in remitted mood disorder patients
This randomized controlled trial evaluated 3 weeks of normobaric hypoxia combined with cognitive training versus treatment-as-usual in 57 pa…
Daily low-oxygen breathing exercises did not change brain scans in people with mood disorders who were already in remission.
Frontiers Apr 9, 2026
Social risk factors show larger effect sizes than polygenic risk scores for bipolar disorder in cohort study
Genetics & Precision Medicine Cohort
Social risk factors show larger effect sizes than polygenic risk scores for bipolar disorder in cohort study What matters more for bipolar disorder: your genes or your life experiences?
A cohort study of 115,275 participants from the All of Us Research Program found that six social risk factors had larger effect sizes than p…
Social factors like stress and childhood trauma are more strongly linked to bipolar disorder than genetic risk, with high social burden some…
medRxiv Apr 8, 2026
Protocol outlines target trial emulation for bipolar disorder treatments in patients with opioid use disorder
Psychiatry RCT
Protocol outlines target trial emulation for bipolar disorder treatments in patients with opioid use disorder Study protocol compares bipolar disorder medications for people with opioid use disorder
This protocol describes a planned target trial emulation study using population-level administrative data from British Columbia and Ontario,…
People with bipolar disorder and opioid use disorder face higher risks, but a new plan will compare how well different medications work for …
medRxiv Apr 4, 2026
FDA Approves Lamotrigine for Adjunctive Therapy in Epilepsy and Maintenance in Bipolar I Disorder
Neurology FDA Approval
FDA Approves Lamotrigine for Adjunctive Therapy in Epilepsy and Maintenance in Bipolar I Disorder FDA approves lamotrigine, a medicine for epilepsy and bipolar disorder
Lamotrigine is approved for adjunctive therapy of partial-onset seizures, PGTC seizures, and seizures of Lennox-Gastaut syndrome in patients…
The FDA officially approves lamotrigine for epilepsy and bipolar disorder, confirming a long-used treatment option for adults and children a…
FDA Apr 2, 2026
FDA Approves Depakote (divalproex sodium) for Manic Episodes Associated with Bipolar Disorder
Neurology FDA Approval
FDA Approves Depakote (divalproex sodium) for Manic Episodes Associated with Bipolar Disorder FDA approves Depakote for treating manic episodes in bipolar disorder
The FDA approved Depakote (divalproex sodium) for the treatment of manic episodes associated with bipolar disorder.
FDA approves Depakote for treating manic episodes in hospitalized adults with bipolar disorder, offering doctors a new option for managing a…
FDA Apr 2, 2026
FDA Approves Depakote ER (divalproex sodium) for Acute Manic or Mixed Episodes in Bipolar Disorder
Neurology FDA Approval
FDA Approves Depakote ER (divalproex sodium) for Acute Manic or Mixed Episodes in Bipolar Disorder FDA approves a new once-daily pill for treating manic episodes in bipolar disorder
The FDA has approved Depakote ER, an extended-release valproate, for the acute treatment of manic or mixed episodes associated with bipolar …
FDA approves a new once-daily pill for short-term treatment of severe manic episodes in adults with bipolar I disorder.
FDA Apr 2, 2026
Meta-analysis identifies distinct and shared amygdala connectivity patterns in major depression and bipolar disorder
Psychiatry Meta-analysis
Meta-analysis identifies distinct and shared amygdala connectivity patterns in major depression and bipolar disorder Do depression and bipolar disorder show different brain wiring patterns?
A voxel-wise meta-analysis of neuroimaging studies compared amygdala functional connectivity in patients with major depressive disorder and …
Brain scans show depression and bipolar disorder have different wiring in memory areas but share abnormalities in emotion control regions.
Apr 2, 2026
Transcriptomic meta-analysis in bipolar disorder identifies mitochondrial, synaptic, and inflammatory pathway genes
Psychiatry Meta-analysis
Transcriptomic meta-analysis in bipolar disorder identifies mitochondrial, synaptic, and inflammatory pathway genes Gene analysis in bipolar disorder finds links to energy, inflammation, and signaling pathways
A meta-analysis of 917 brain and 638 blood samples from BD patients and controls found enrichment of genes involved in mitochondrial bioener…
Gene analysis reveals that bipolar disorder disrupts brain energy production, stress response, and inflammation pathways, pointing to specif…
Apr 2, 2026
Insomnia's association with cognitive function studied in 170 bipolar disorder outpatients
Psychiatry
Insomnia's association with cognitive function studied in 170 bipolar disorder outpatients Study examines link between insomnia and thinking problems in bipolar disorder
An observational study examined 170 outpatients with bipolar disorder to assess insomnia's relationship with cognitive functioning.
People with bipolar disorder who struggle to sleep may also face thinking problems, though this study only shows a connection without provin…
Frontiers Mar 30, 2026

Questions about Bipolar Disorder

Can changes in gut bacteria help manage symptoms of bipolar disorder and depression?

Early research shows gut bacteria differ in people with bipolar disorder and depression, but it's too soon to say whether changing gut bacteria can manage symptoms.

Full answer →
Are there lower levels of GDNF in the blood of people with bipolar disorder?

Research suggests GDNF levels may be lower in people with bipolar disorder, especially during manic episodes, but findings are mixed and not definitive.

Full answer →
What does the research say about psychosis rates in people with bipolar disorder?

A large meta-analysis found that about 47% of people with bipolar disorder experience mood-incongruent psychosis, and psychotic symptoms are common, especially in bipolar I disorder.

Full answer →