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

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT05061706

Run by

Intra-Cellular Therapies, Inc.

People needed

480

Starts

2021-09-30

Expected to finish

2024-04-12

Last updated by the study team

2025-05-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients between the ages of 18 and 65 years, inclusive;
• 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:
• The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening;
• Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
• Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening (Visit 1) and at Baseline;
• Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
• 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.
• 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:
• citalopram/escitalopram
• fluoxetine
• paroxetine
• sertraline
• duloxetine
• levomilnacipran/milnacipran (if locally approved for MDD)
• venlafaxine/desvenlafaxine
• bupropion
• vilazodone
• vortioxetine

You may not qualify if…

• Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
• Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
• Bipolar Disorder;
• Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
• Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses.
• Eating disorder;
• Substance use disorders (excluding nicotine);
• Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
• Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
• The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
• The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
• 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;
• At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;
• At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
• The patient is considered to be in imminent danger to him/herself or others.
• The patient has a first MDE at age 60 years or older.

Where it is running

• 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

Full record on ClinicalTrials.gov

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