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Home › Conditions › Bipolar I Disorder

Bipolar I Disorder

Part of Bipolar Disorder

3 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Bipolar I Disorder

42 trials tracked for Bipolar I Disorder: 26 in phase 3 or 4 and 11 with published results. The most-cited published study has 133 citations.

42Trials tracked
26Phase 3 & 4
0Recruiting
11With published results
Phase distribution
Phase 4 4 Phase 3 22 Phase 2 11 Phase 1 2 Other / NA 3
  1. Phase 3 Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients Completed · 133 cited
  2. Phase 3 Safety and Efficacy of Cariprazine for Bipolar I Disorder Completed · 121 cited
  3. Phase 3 Sensoril(Ashwaganhda)for Bipolar Disorder Completed · 117 cited
  4. Phase 3 Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder Completed · 36 cited
  5. Phase 4 Sequential Multiple Assignment Treatment for Bipolar Disorder Completed · 29 cited
  6. Phase 4 The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression. Completed · 19 cited
Show 36 more trials
  1. Phase 3 Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder Completed · 16 cited
  2. Phase 3 Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder Completed · 11 cited
  3. Phase 3 A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder. Completed · 10 cited
  4. Phase 3 Staccato Loxapine in Agitated Patients With Bipolar Disorder Completed · 10 cited
  5. Phase 3 Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 Completed · 7 cited
  6. Phase 4 A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients Completed
  7. Phase 4 Study in Adolescents With Schizophrenia or Bipolar Disorder Completed
  8. Phase 3 Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex Completed
  9. Phase 3 This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296 Completed
  10. Phase 3 A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder Completed
  11. Phase 3 A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder Completed
  12. Phase 3 A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder. Completed
  13. Phase 3 A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features Completed
  14. Phase 3 A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode Completed
  15. Phase 3 Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed Completed
  16. Phase 3 A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode Completed
  17. Phase 3 A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode Completed
  18. Phase 3 Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder Completed
  19. Phase 3 Risperdal Consta for Bipolar Disorder Completed
  20. Phase 3 A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode Completed
  21. Phase 2 Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain Completed
  22. Phase 2 Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder Completed
  23. Phase 2 Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents Completed
  24. Phase 2 Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders Completed
  25. Phase 2 A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode Completed
  26. Phase 2 Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder Completed
  27. Phase 2 Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder Completed
  28. Phase 2 Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System Completed
  29. Phase 2 A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder Completed
  30. Phase 2 Gabapentin for Bipolar & Cannabis Use Disorders Completed
  31. Phase 2 Treating Smokers With Mental Illness Completed
  32. Phase 1 A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1) Completed
  33. Phase 1 A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020) Completed
  34. N/A iTBS in Bipolar I Depression Completed
  35. N/A Targeting Cerebellum to Treat Psychosis: a Transcranial Magnetic Stimulation (TMS) Study Completed
  36. N/A A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion Completed

Showing the 42 most-cited and recently-updated of 42 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 For clinicians

Bipolar I Disorder: what the trials found

Several antipsychotic agents have demonstrated efficacy in managing manic symptoms for Bipolar I Disorder. Cariprazine showed significant reductions in Young Mania Rating Scale (YMRS) scores at week 3 6 and week 16 8, as well as improvements in Clinical Global Impression-Severity (CGI-S) scores 6. Olanzapine was associated with significant reductions in YMRS scores [3, 4] and HAMD scores 4. Brexpiprazole demonstrated changes in YMRS scores at week 3 [16, 17], while Lurasidone showed a reduction of -1.0 in YMRS total score by week 12 18.

Long-term management and maintenance are supported by various formulations. IM Depot Aripiprazole significantly extended the time to recurrence of any mood episode compared to placebo 5 and improved CGI-BP-S (Mania) scores 5. Oral Aripiprazole also showed a reduction in CGI-BP severity for mania 21. Staccato Loxapine demonstrated significant improvements in Clinical Global Impression-Improvement (CGI-I) scores and reductions in the PANSS Excited Component (PEC) score after a single dose compared to placebo 11.

Weight gain is a noted outcome in some trials; for example, ALKS 3831 was associated with significant increases in body weight at week 12 9. Olanzapine was evaluated regarding BMI changes over 52 weeks, which did not reach statistical significance 3.

Recent results — preliminary, needs further review

  • Ketamine Hydrochloride was evaluated in a Phase 4 trial for Bipolar I Disorder 2.

For the clinician treating this condition

  • Cariprazine and Olanzapine are supported by evidence for reducing manic symptoms as measured by YMRS scores [3, 4, 6, 8].
  • IM Depot Aripiprazole and oral Aripiprazole provide established options for managing mania and preventing mood episode recurrence [5, 21].
  • Staccato Loxapine showed rapid improvement in clinical global impression and excited components after a single dose 11.

AI synthesis of 10 cited trials, updated Jun 26, 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.
Unipolar mania prevalence in patients with bipolar type I disorder is 21.1%
Psychiatry Meta-analysis
Unipolar mania prevalence in patients with bipolar type I disorder is 21.1% About one in five people with bipolar disorder experience mania
This meta-analysis of 35 independent samples indicates a pooled prevalence of unipolar mania (UM) in adults with bipolar type I disorder of …
New data shows that over 20% of adults with bipolar type I disorder experience unipolar mania, highlighting a need for better clinical aware…
Jul 18, 2026
FDA Approves Lamotrigine Tablets (lamotrigine) for Epilepsy and Bipolar Disorder Maintenance
Neurology FDA Approval
FDA Approves Lamotrigine Tablets (lamotrigine) for Epilepsy and Bipolar Disorder Maintenance The FDA has approved a drug called lamotrigine for epilepsy and bipolar disorder treatment
Lamotrigine tablets were approved as adjunctive therapy for partial-onset seizures, PGTC seizures, and Lennox-Gastaut syndrome in patients a…
The FDA has approved lamotrigine to help control seizures in children as young as two and maintain mood stability for adults with bipolar di…
FDA Apr 14, 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

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