Study of Lumateperone in the Treatment of Patients With Bipolar Mania

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

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called Lumateperone to see if it can help treat patients with bipolar I disorder who are experiencing manic episodes. The study is focused on individuals between the ages of 18 and 75 who have been diagnosed with bipolar mania, which can include symptoms like extreme mood swings and, in some cases, psychotic symptoms. Participants will be randomly assigned to receive either the medication or a placebo (a pill that looks the same but has no active ingredients) to compare the effects.

To be eligible for the trial, participants must be hospitalized due to their current manic episode and have a specific level of symptoms as measured by a scale. They should not have any other major psychiatric disorders and must be able to give consent to participate. Those who join the study can expect to be closely monitored by healthcare professionals and will have their symptoms assessed throughout the trial. It's important for potential participants to know that the study aims to find new treatment options for bipolar mania, which could ultimately improve care for others facing this condition.

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.