For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

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

Meets DSM-5 criteria for MDD as confirmed by 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 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. 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:

  1. citalopram/escitalopram
  2. fluoxetine
  3. paroxetine
  4. sertraline
  5. duloxetine
  6. levomilnacipran/milnacipran (if locally approved for MDD)
  7. venlafaxine/desvenlafaxine
  8. buproprion
  9. vilazodone
  10. vortioxetine


Exclusion Criteria:

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;

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;
  6. The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
  7. 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:

  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.
  5. The patient has a first MDE at age 60 years or older.
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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Major Depressive Disorder

Age (in years)

18 - 65


Phase 3

Participants needed


Est. Completion Date

Feb 29, 2024

Treatment type



Intra-Cellular Therapies, Inc. identifier


Study number


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