Clinical Trial 56898

Huntsville, AL 35801


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.

Inclusion Criteria:

  1. Male or female patients between the ages of 18 and 65 years, inclusive;
  2. Currently depressed with diagnosis of Major Depressive Disorder (MDD) (MDD with psychotic features will be acceptable); 

  3. Currently having an inadequate response to ADT 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. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;
    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

Qualified Participants May Receive:


Available At:

UAB Huntsville Regional Medical Campus
301 Governors Drive SW
Huntsville, AL 35801
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If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.