Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850689
• Other study ID #: ITI-007-505
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2, 2023
• Est. completion date: October 2025

Study information

• Verified date: January 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 parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.

Description:

The study will be conducted in three periods:

• Screening Period (up to 2 weeks) during which patient eligibility will be assessed.

• Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio.

• Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female patients between the ages of 18 and 65 years, inclusive;

2. Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or 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:

1. The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening;

2. Has at least moderate severity of illness based on rater-administered MADRS total score = 24 at Screening and at Baseline;

3. Has at least moderate severity of illness based on CGI-S score = 4 at Screening and at Baseline;

4. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score = 14 at Screening and at Baseline;

5. Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.

3. Currently having an inadequate response to ADT (less than 50% improvement) as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration:

1. citalopram/escitalopram

2. fluoxetine

3. paroxetine

4. sertraline

5. duloxetine

6. levomilnacipran/milnacipran (if locally approved for MDD)

7. venlafaxine/desvenlafaxine

8. bupropion

9. vilazodone

10. vortioxetine

Exclusion Criteria:

1. Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:

1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;

2. Bipolar Disorder;

2. Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:

1. Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;

2. Eating disorder;

3. Substance use disorders (excluding nicotine);

4. Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;

5. Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;

3. The patient experiences a = 25% decrease in the MADRS total score between Screening and Baseline;

4. The patient experiences a = 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;

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

1. At Screening, the patient scores "yes" on Suicidal Ideation Items 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 4 or 5 since the Screening Visit;

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

3. At Screening or Baseline, the patient scores = 5 on MADRS Item 10 (Suicidal Thoughts), or

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

6. The patient has a first MDE at age 60 years or older.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
• Placebo
Matching capsules administered orally, once daily

Locations

Country	Name	City	State
United States	Clinical Site	Avon Lake	Ohio
United States	Clinical Site	Clermont	Florida
United States	Clinical Site	Columbus	Ohio
United States	Clinical Site	Decatur	Georgia
United States	Clinical Site	Farmington	Connecticut
United States	Clinical Site	Hialeah	Florida
United States	Clinical Site	Houston	Texas
United States	Clinical Site	Kansas City	Kansas
United States	Clinical Site	Methuen	Massachusetts
United States	Clinical Site	Miami	Florida
United States	Clinical Site	Miami	Florida
United States	Clinical Site	New York	New York
United States	Clinical Site	O'Fallon	Missouri
United States	Clinical Site	Overland Park	Kansas
United States	Clinical Site	Philadelphia	Pennsylvania
United States	Clinical Site	Pico Rivera	California
United States	Clinical Site	Richardson	Texas
United States	Clinical Site	Tampa	Florida

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	Montgomery-Asberg Depression Rating Scale	The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.	Day 43
Secondary	Clinical Global Impression Scale-Severity	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).	Day 43