Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Bipolar Depression Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372964
• Other study ID #: ITI-007-421
• Status: Recruiting
• Phase: Phase 3
• Start date: April 2024
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Intra-Cellular Therapies, Inc.
• Contact: ITI Clinical Trials
• Phone: 646 440-9333
• Email: ITCIClinicalTrials[@]itci-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Description:

The study will be conducted in 3 phases: - Screening Period (up to 2 weeks) during which patient eligibility will be assessed - Double-blind Treatment Period (6 weeks) during which all patients will be randomized to receive lumateperone 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 (SFU) visit approximately one week after the last dose of study drug.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: May 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Able to provide consent as follows:

• The Legally Authorized Representative (LAR) must provide written, informed consent.
• The patient must provide written assent;

2. Male or female patients 10 to 17 years of age, inclusive;

3. Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);

4. Subject has a lifetime history of at least one manic or hypomanic episode.

5. Subject's current major depressive episode is = 4 weeks and less than 12 months in duration;

6. CDRS-R total score = 45 with = 5 on Item 11 (depressed feelings) at Screening and Baseline;

7. Young Mania Rating Scale (YMRS) score = 15 (with YMRS Item 1 [elevated mood] score = 2) at Screening and Baseline.

Exclusion Criteria:

1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder.

Exception includes:

• Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.

2. Intellectual disability based on Investigator opinion and DSM-5 criteria

3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;

4. Demonstrates a = 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;

5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or

1. At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;

2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or

3. At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) on the CDRS-R; or

4. The patient is considered to be an imminent danger to him/herself or others.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Lumateperone
Lumateperone administered orally, once daily.
• Placebo
Matching placebo administered orally, once daily.

Locations

Country	Name	City	State
United States	Clinical Site	Anaheim	California
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Austin	Texas
United States	Clinical Site	Avon Lake	Ohio
United States	Clinical Site	Baltimore	Maryland
United States	Clinical Site	Bellevue	Washington
United States	Clinical Site	Chicago	Illinois
United States	Clinical Site	Cincinnati	Ohio
United States	Clinical Site	Colorado Springs	Colorado
United States	Clinical Site	Decatur	Georgia
United States	Clinical Site	Frisco	Texas
United States	Clinical Site	Gainesville	Florida
United States	Clinical Site	Garfield	Ohio
United States	Clinical Site	Hialeah	Florida
United States	Clinical Site	Houston	Texas
United States	Clinical Site	Houston	Texas
United States	Clinical Site	Indianapolis	Indiana
United States	Clinical Site	Kinston	North Carolina
United States	Clinical Site	Lawrenceville	Georgia
United States	Clinical Site	Lincoln	Nebraska
United States	Clinical Site	Miami Lakes	Florida
United States	Clinical Site	Miami Lakes	Florida
United States	Clinical Site	Miami Springs	Florida
United States	Clinical Site	Oklahoma City	Oklahoma
United States	Clinical Site	Oklahoma City	Oklahoma
United States	Clinical Site	Orlando	Florida
United States	Clinical Site	Sacramento	California
United States	Clinical Site	Saint Charles	Missouri
United States	Clinical Site	San Diego	California
United States	Clinical Site	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Depression Rating Scale-Revised (CDRS-R)	The Children's Depression Rating Scale-Revised is an observer-rated, 17-item semi-structured scale for pediatric patients. The scale comprises cognitive, somatic, affective, and psychomotor symptoms of depression. Items are rated for severity on a 7-point scale (1 to 7) for 14 items and on a 5-point scale (1 to 5) for three items. Total scores range from 7 to 113.	Week 6
Secondary	Clinical Global Impression Scale-Severity (CGI-S)	The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).	Week 6