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

Recruiting now · 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

NCT05850689

Run by

Intra-Cellular Therapies, Inc.

People needed

470

Starts

2023-05-02

Expected to finish

2027-04-05

Last updated by the study team

2026-07-31

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 modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria:
• The start of the current major depressive episode (MDE) is at least 12 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 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 (less than 50% improvement) to 2 or more ADTs in the current MDE 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:
• 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. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;
• 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

• Medical Center Medconsult-Pleven — Pleven, Bulgaria (enrolling)
• Medical Center Mentalcare OOD — Plovdiv, Bulgaria (enrolling)
• CNRI-Los Angeles, LLC — Pico Rivera, California, United States (enrolling)
• Medical Center Lifemed — Kardzhali, Bulgaria (enrolling)
• University of Connecticut Health Center — Farmington, Connecticut, United States (enrolling)
• Miami Jewish Health System — Miami, Florida, United States (enrolling)
• Interventional Psychiatry of Tampa Bay — Tampa, Florida, United States (enrolling)
• The Emory Clinic — Atlanta, Georgia, United States (enrolling)
• CenExeli Research LLC — Decatur, Georgia, United States (enrolling)
• Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET — Cherven Bryag, Bulgaria (enrolling)
• Collective Medical Research — Overland Park, Kansas, United States (enrolling)
• Premier Clinical Research Institute — Miami, Florida, United States (enrolling)
• Psychiatric Care and Research Center (PCRC) — O'Fallon, Missouri, United States (enrolling)
• Bio Behavioral Health — Toms River, New Jersey, United States (enrolling)
• SPRI Clinical Trials, LLC — Brooklyn, New York, United States (enrolling)
• Manhattan Behavioral Medicine — New York, New York, United States (enrolling)
• Quest Therapeutics of Avon Lake — Avon Lake, Ohio, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Pennsylvania - Perelman School of Medicine — Philadelphia, Pennsylvania, United States (enrolling)
• DM Clinical Research — Houston, Texas, United States (enrolling)
• University of Alabama at Birmingham — Huntsville, Alabama, United States (enrolling)
• Pillar Clinical Research, LLC — Richardson, Texas, United States (enrolling)
• Northwest Clinical Research Center — Bellevue, Washington, United States (enrolling)
• MHC - Sofia, EOOD — Sofia, Bulgaria (enrolling)

Full record on ClinicalTrials.gov

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