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Treatment of bipolar mania with lumateperone

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)

Phase 3 Interventional Intra-Cellular Therapies, Inc. · NCT06462586

This study is testing if a new medication called lumateperone can help people with bipolar I disorder who are having manic episodes feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorIntra-Cellular Therapies, Inc. Industry-sponsored
Locations42 sites (Rogers, Arkansas and 41 other locations)
Trial IDNCT06462586 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy of lumateperone in treating patients diagnosed with bipolar I disorder experiencing manic episodes. The study involves a screening period to assess eligibility, followed by a three-week treatment phase where participants receive either lumateperone or a placebo. After the treatment, there is a one-week safety follow-up to monitor any adverse effects. The study adheres to the DSM-5 criteria for bipolar disorder and utilizes the YMRS scale to measure symptom severity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who are currently hospitalized with a diagnosis of bipolar I disorder and experiencing manic episodes.

Not a fit: Patients with bipolar disorder who are not currently experiencing manic episodes or those with other psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing acute manic episodes in bipolar disorder patients.

How similar studies have performed: Previous studies have shown promise in treating bipolar mania with similar pharmacological approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Able to provide written informed consent before the initiation of any study specific procedures;
2. Male or female inpatient, between the ages of 18 and 75 years, inclusive;
3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);
4. YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline;
5. Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not \> 14 days before Screening. Hospital admission must be a result of the current manic episode.

Exclusion Criteria:

1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:

   1. Schizophrenia, schizoaffective disorder, or other psychotic disorders;
   2. Dementia or other cognitive disorders;
   3. Intellectual disability;
   4. Moderate or severe substance use disorder (excluding for nicotine);
2. Experiencing first manic episode;
3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or

   1. At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or
   2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
   3. At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or
   4. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
   5. Considered to be an imminent danger to himself/herself or others.

Where this trial is running

Rogers, Arkansas and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bipolar Disorder, Manic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.