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A study to assess the efficacy and safety of lumateperone in patients with Bipolar Mania
EU CTIS ID: 2024-513037-20-00
What this study is testing
The primary efficacy objective of this study is to assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the acute treatment of patients with manic episodes or manic episodes with mixed features associated with bipolar I disorder, as measured by change from baseline to end of Week 3 in Young Mania Rating Scale (YMRS) total score.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient provides written informed consent;
- Male or female inpatient, between the ages of 18 and 75 years, inclusive
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision 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) and meets all of the following criteria: a. The start of the current manic or manic with mixed features episode is ≤ 4 weeks prior to Screening (Visit 1); b. 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 (Visit 1) and Baseline (Visit 2); c. Have at least moderate severity of illness based on CGI-S total score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2);
- Hospitalized voluntarily before Screening (Visit 1) or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not > 14 days before Screening (Visit 1). Hospital admission must be a result of the current manic episode;
You likely can't join if
- Has a current primary DSM-5 psychiatric diagnosis other than bipolar disorder. These include: - Schizophrenia, schizoaffective disorder, or other psychotic disorders; - Dementia or other cognitive disorders; - Intellectual disability; - Moderate or severe substance use disorder (excluding for nicotine);
- Experiencing first manic episode
- 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 - At Screening (Visit 1), 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 - At Screening (Visit 1), the patient has had 1 or more suicidal attempts within 2 years prior to Screening (Visit 1); or - At Baseline (Visit 2), the patient scores “yes” on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or o At Screening (Visit 1) or Baseline (Visit 2), scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or - Considered to be an imminent danger to himself/herself or others.
- The patient has received electroconvulsive therapy (ECT), vagal nerve stimulation, or repetitive trans-cranial magnetic stimulation within the past 1 year.
- The patient has known hypersensitivity or intolerance to lumateperone, or to any of the excipients
The study team makes the final eligibility decision.
Where it's taking place
- United States
- India
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; India; Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.