Today, we will be looking into the latest research and clinical trials focused on bipolar disorder.

The following list has been carefully curated by evaluating the ongoing phase 3 trials for bipolar disorder, targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.

This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.

Now, let’s go ahead and explore the list of Bipolar Disorder Clinical Trials!

Quick View Table of Bipolar Disorder Clinical Trials
Study TitlePhaseEnrollmentStart DateLast Update Posted
Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar PatientsPHASE 31005/8/20172/14/2025
Study of Lumateperone in the Treatment of Patients With Bipolar ManiaPHASE 33507/17/20247/29/2024
Study of Lumateperone in the Acute Treatment of Patients With Bipolar ManiaPHASE 33506/19/20247/29/2024
Efficacy and Safety of Endoxifen in Bipolar I Disorder PatientsPHASE 34903/19/20243/17/2025
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I DisorderPHASE 34173/22/20214/18/2024
Aripiprazole for Bipolar Disorder and Alcohol Use DisorderPHASE 37511/1/20169/19/2024
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)PHASE 345011/21/20223/12/2025
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831PHASE 35236/15/20179/26/2024

Phase 3 Clinical Trials:

Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients

Study Details | Source

  • Sponsor: Lakshmi N Yatham
  • This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomized at the baseline visit to receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.
  • Interventions:
    • Drug: Lurasidone
    • Other: Placebo
  • Primary Outcome Measures:
    • Improvement in cognitive performance in euthymic bipolar patients treated with lurasidone vs placebo adjunctive therapy. 
    • Cognitive improvement measured by changes in composite cognitive score from baseline to endpoint.
      • Time Frame - 6 weeks

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

Study Details | Source

  • Sponsor: Intra-Cellular Therapies, Inc.
  • This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
  • Interventions:
    • Drug: Lumateperone
    • Drug: Placebo
  • Primary Outcome Measures:
    • YMRS (Young Mania Rating Scale) score to assess the severity of manic symptoms.
    • The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms.
      • Time Frame - Week 3

Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

Study Details | Source

  • Sponsor: Intra-Cellular Therapies, Inc.
  • This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
  • Interventions:
    • Drug: Lumateperone
    • Drug: Placebo
  • Primary Outcome Measures:
    • YMRS score to assess the severity of manic symptoms.
    • The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms.
      • Time Frame - Week 3

Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

Study Details | Source

  • Sponsor: Jina Pharmaceuticals Inc.
  • Bipolar disorder (BPD) is a chronic debilitating illness characterized by drastic swings in mood, energy and functional ability that affects the adult population. Endoxifen is an active metabolite of the marketed drug Tamoxifen and the present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the Bipolar I disorder patient population compared to a placebo arm. Endoxifen will be compared to a placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is
  • Interventions:
    • Drug: Endoxifen (8 mg enteric-coated tablet)
    • Drug: Placebo Tablets
  • Primary Outcome Measures:
    • Efficacy - mean change from baseline to Day 21 in the total YMRS score
    • Primary efficacy endpoint will be the mean change from baseline to Day 21 in the total YMRS score. The point estimate and 95% confidence interval for the mean change from Day 0 (baseline) to Day 21 in total YMRS score for the difference between test and placebo control treatment will be computed and reported for mITT set. Superiority of test over placebo will be claimed if 95% confidence interval for mean change from Day 0 (baseline) to Day 21 in total YMRS score for the difference between test and placebo control treatment will exclude zero for mITT set.
      • Time Frame - 27 days

Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

Study Details | Source

  • Sponsor: Vanda Pharmaceuticals
  • The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.
  • Interventions:
    • Drug: Iloperidone
    • Drug: Iloperidone Placebo
  • Primary Outcome Measures:
    • Change from baseline in YMRS total score at Week 4.
    • The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).
      • Time Frame - Week 4

Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Study Details | Source

  • Sponsor: University of Texas Southwestern Medical Center
  • The investigators will conduct a 12-week, randomized, double-blind, parallel-group, placebo-controlled study of aripiprazole in 132 persons with Alcohol Use Disorder (AUD) and bipolar I or II disorder, currently depressed or mixed phase. Primary Aim will be to assess change in alcohol use by the Timeline Followback (TLFB) method. Secondary Aim will include change in alcohol craving using the Penn Alcohol Craving Scale (PACS). Changes in psychiatric symptoms (mania/hypomania and depression) and predictors of response will be assessed. Participants with ≥ 1 drinking day at week 12 will be enrolled in a 4-week extension phase with an upward titration to 30 mg/day for those in the active treatment group. The placebo group will remain on placebo.
  • Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder and AUD, development of active suicidal or homicidal ideation with plan and intent, worsening in mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe or life-threatening medical condition, involuntary psychiatric hospitalization or incarceration, significant alcohol withdrawal (e.g. delirium tremens) based on clinical judgment (increases in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores will initiate a careful clinical assessment of possible worsening of withdrawal symptoms), or cocaine or amphetamine-positive urine drug screen during the study.
  • Interventions:
    • Drug: Aripiprazole
    • Drug: Placebo
  • Primary Outcome Measures:
    • Timeline Follow Back (TLFB)
    • The Timeline Followback (TLFB) is used to assess recent alcohol use (and if present, other substance use). The calculation is based on the change between baseline and week 12.
      • Time Frame - 12 weeks

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

Study Details | Source

  • Sponsor: BioXcel Therapeutics Inc.
  • In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
  • Interventions:
    • Drug: BXCL501
    • Drug: Matching Placebo
  • Primary Outcome Measures:
    • Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score
    • The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
      • Time Frame - 2 hours 
    • Part 2: The incidence of SAEs and TEAEs compared with placebo.
    • To assess the safety of 120 mcg BXCL501 when used in an at-home environment based on serious adverse events (SAE) and treatment emergent adverse events (TEAEs).
      • Time Frame - Average of 12 weeks 

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Study Details | Source

  • Sponsor: Alkermes, Inc.
  • This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder
  • Interventions:
    • Drug: ALKS 3831
  • Primary Outcome Measures:
    • Incidence of Adverse Events
      • Up to 48 months
    • Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
    • The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients
      • Time Frame - Up to 48 months

Potential Guidelines That May Be Affected Include:

And there you have it - a roundup of Phase 3 clinical trials for bipolar disorder as of March 2025. Stay tuned for our next Guidelines+ Trials Rundown! In the meantime, explore more clinical trials and sign up for alerts to stay up to date with the latest published guidelines and research.

Copyright © 2025 Guideline Central, All Rights Reserved.