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

Launched by INTRA-CELLULAR THERAPIES, INC. · Jun 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Lumateperone to see how well it works in treating people with bipolar disorder during a manic episode. Bipolar disorder is a mental health condition that can cause extreme mood swings, including episodes of mania, where a person may feel overly energetic, irritable, or aggressive. The study is specifically looking for adults aged 18 to 75 who have been diagnosed with bipolar I disorder and are currently experiencing mania, either with or without psychotic symptoms.

To participate, eligible individuals must be hospitalized for their manic episode and able to provide written consent for the study. Participants will be randomly assigned to receive either Lumateperone or a placebo (a non-active treatment) without knowing which one they are receiving. Throughout the trial, participants will be monitored for their symptoms and overall well-being. This study aims to gather more information about Lumateperone's effectiveness and safety in treating bipolar mania, which could potentially help improve treatment options for this condition in the future.

Gender

ALL

Eligibility 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.