Health Condition 1: F316- Bipolar disorder, current episodemixed
Conditions
Interventions
Intervention1: Lumateperone: Route: Oral
Dose: Formulated Capsules (42 mg)
Frequency: Once daily in the evening
Control Intervention1: Placebo: Route: Oral Dose
Formulation: capsule
Frequency: Once d
Sponsors
Intra-Cellular Therapies, Inc.
IQVIA RDSIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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, (DSM-5-TR, American Psychiatric Association, 2022) 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) 4. Hospitalized voluntarily before Screening (Visit 1) or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not greater than 14 days before Screening (Visit 1). Hospital admission must be a result of the current manic episode. 5. Female of childbearing potential and agrees to use at least an acceptable method of birth control (including but not limited to hormonal contraception, intrauterine device, vasectomized partner, bilateral tubal occlusion, condom with or without spermicide, cap with spermicide, diaphragm with spermicide, sponge with spermicide, or double barrier methods) from the time informed consent is provided through the end of the SFU period. Abstinence may be an acceptable form of birth control based on the Investigator’s judgment and familiarity with the patient’s “preferred and usual lifestyle 6. Ability to follow study instructions and likely to complete all required visits
Exclusion criteria
Exclusion criteria: 1. Has a current primary DSM-5 psychiatric diagnosis other than bipolar disorder. These include: a. Schizophrenia, schizoaffective disorder, or other psychotic disorders. b. Dementia or other cognitive disorders. c. Intellectual disability. d. 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 a. 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 b. At Screening (Visit 1), the patient has had 1 or more suicidal attempts within 2 years prior to Screening (Visit 1); or c. 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 d. At Screening (Visit 1) or Baseline (Visit 2), scores less than or equal to 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or e. Considered to be an imminent danger to himself/herself or others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Clinical Global Impression-Severity (CGI-S) score.Timepoint: 3weeks | — |
Countries
Bulgaria, Croatia, India, Serbia, United States of America
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed