A study to assess the efficacy and safety of lumateperone in patients with Bipolar Mania
Key facts
- Where
- Burgas, Kazanlik, Sliven, and Sofia, BulgariaSee the 4 sites
- Phase
- Phase 3
Where in Bulgaria
- Center For Mental Health Prof. Dr. Ivan Temkov Burgas EOODBurgas, BulgariaNo longer taking part
- Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOODKazanlik, BulgariaNo longer taking part
- MBAL Dr. Ivan Seliminski Sliven ADSliven, BulgariaNo longer taking part
- Alexandrovska University HospitalSofia, BulgariaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Intra-Cellular Therapies Inc.
- Trial code
- EU 2024-513037-20-00
- Record updated
- 19 May 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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; 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); The patient has known hypersensitivity or intolerance to lumateperone, or to any of the excipients; Experiencing first manic episode.