- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05850689
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: ITI Clinical Trials
- Phone Number: 646 440-9333
- Email: ITCIClinicalTrials@itci-inc.com
Study Locations
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California
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Pico Rivera, California, United States, 90660
- Recruiting
- Clinical Site
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Connecticut
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Farmington, Connecticut, United States, 06030
- Recruiting
- Clinical Site
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Florida
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Clermont, Florida, United States, 34711
- Recruiting
- Clinical Site
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Hialeah, Florida, United States, 33012
- Recruiting
- Clinical Site
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Miami, Florida, United States, 33122
- Recruiting
- Clinical Site
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Miami, Florida, United States, 33180
- Not yet recruiting
- Clinical Site
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Tampa, Florida, United States, 33629
- Recruiting
- Clinical Site
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Georgia
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Decatur, Georgia, United States, 30030
- Recruiting
- Clinical Site
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Kansas
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Kansas City, Kansas, United States, 66160
- Recruiting
- Clinical Site
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Overland Park, Kansas, United States, 66210
- Not yet recruiting
- Clinical Site
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Massachusetts
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Methuen, Massachusetts, United States, 01844
- Recruiting
- Clinical Site
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Missouri
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O'Fallon, Missouri, United States, 63368
- Recruiting
- Clinical Site
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New York
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New York, New York, United States, 10036
- Recruiting
- Clinical Site
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Ohio
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Avon Lake, Ohio, United States, 44012
- Recruiting
- Clinical Site
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Columbus, Ohio, United States, 43210
- Recruiting
- Clinical Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Clinical Site
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Texas
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Houston, Texas, United States, 77081
- Recruiting
- Clinical Site
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Richardson, Texas, United States, 75080
- Not yet recruiting
- Clinical Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 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 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 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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Matching capsules administered orally, once daily
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Experimental: Lumateperone 42 mg
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Lumateperone 42 mg capsules administered orally, once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery-Asberg Depression Rating Scale
Time Frame: Day 43
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression Scale-Severity
Time Frame: Day 43
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITI-007-505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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