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

NCT ID: NCT05061706

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2024-04-12

Brief 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.

Detailed 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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lumateperone 42 mg

Group Type: EXPERIMENTAL

Lumateperone

Intervention Type: DRUG

Lumateperone 42 mg capsules administered orally, once daily.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching capsules administered orally, once daily.

Interventions

Lumateperone

Lumateperone 42 mg capsules administered orally, once daily.

Intervention Type: DRUG

Placebo

Matching capsules administered orally, once daily.

Intervention Type: DRUG

Eligibility Criteria

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 MINI 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 (Visit 1) 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 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Site

Little Rock, Arkansas, United States

Clinical Site

Rogers, Arkansas, United States

Clinical Site

Newport Beach, California, United States

Clinical Site

Riverside, California, United States

Clinical Site

San Diego, California, United States

Clinical Site

Palm Bay, Florida, United States

Clinical Site

West Palm Beach, Florida, United States

Clinical Site

Atlanta, Georgia, United States

Clinical Site

Overland Park, Kansas, United States

Clinical Site

Gaithersburg, Maryland, United States

Clinical Site

Flowood, Mississippi, United States

Clinical Site

Brooklyn, New York, United States

Clinical Site

Charlotte, North Carolina, United States

Clinical Site

Allentown, Pennsylvania, United States

Clinical Site

Media, Pennsylvania, United States

Clinical Site

Plymouth Meeting, Pennsylvania, United States

Clinical Site

Bellevue, Washington, United States

Clinical Site

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Clinical Site

Córdoba, Córdoba Province, Argentina

Clinical Site

Córdoba, Córdoba Province, Argentina

Clinical Site

Córdoba, Córdoba Province, Argentina

Clinical Site

Córdoba, Córdoba Province, Argentina

Clinical Site

Mendoza, Mendoza Province, Argentina

Clinical Site

Rosario, Santa Fe Province, Argentina

Clinical Site

Buenos Aires, , Argentina

Clinical Site

Plovdiv, , Bulgaria

Clinical Site

Sofia, , Bulgaria

Clinical Site

Sofia, , Bulgaria

Clinical Site

Targovishte, , Bulgaria

Clinical Site

Helsinki, , Finland

Clinical Site

Oulu, , Finland

Clinical Site

Bad Homburg, , Germany

Clinical site

Freiburg im Breisgau, , Germany

Clinical Site

Hamburg, , Germany

Clinical Site

Mittweida, , Germany

Clinical Site

Schwerin, , Germany

Clinical Site

Westerstede, , Germany

Clinical Site

Bełchatów, , Poland

Clinical Site

Bialystok, , Poland

Clinical Site

Bialystok, , Poland

Clinical Site

Bialystok, , Poland

Clinical Site

Bydgoszcz, , Poland

Clinical Site

Gdansk, , Poland

Clinical Site

Gorlice, , Poland

Clinical Site

Leszno, , Poland

Clinical Site

Pruszcz Gdański, , Poland

Clinical Site

Torun, , Poland

Clinical Site

Wroclaw, , Poland

Clinical Site

Lund, , Sweden

Clinical Site

Stockholm, , Sweden

Countries

United States; Argentina; Bulgaria; Finland; Germany; Poland; Sweden

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ITI-007-502

Identifier Type: -

Identifier Source: org_study_id