Clinical trial NCT06462612: Study of Lumateperone in the Treatment of Patients With Bipolar Mania
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bipolar Disorder, Manic
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Detailed description: The study will be conducted in 3 phases:

* Screening Period (up to 1 week) during which patient eligibility will be assessed.
* Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.
* Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit

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.

Primary outcomes:
measure: Young Mania Rating Scale (YMRS)
timeFrame: Week 3
Secondary outcomes:
measure: Clinical Global Impression Scale-Severity (CGI-S)
timeFrame: Week 3
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Clinical Site
state: Arkansas
city: Little Rock
country: United States
facility: Clinical Site
state: Arkansas
city: Anaheim
country: United States
facility: Clinical Site
state: California
city: Cerritos
country: United States
facility: Clinical Site
state: California
city: Orange
country: United States
facility: Clinical Site
state: California
city: Torrance
country: United States
facility: Clinical Site
state: California
city: Hialeah
country: United States
facility: Clinical Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Tampa
country: United States
facility: Clinical Site
state: Florida
city: West Palm Beach
country: United States
facility: Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Site
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Clinical Site
state: Illinois
city: Glen Oaks
country: United States
facility: Clinical Site
state: New York
city: Cincinnati
country: United States
facility: Clinical Site
state: Ohio
city: Richardson
country: United States
facility: Clinical Site
state: Texas
Study officials:
References: