Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability

This is an interventional treatment trial for Major Depressive Disorder and Irritability focused on measuring Major Depressive Disorder, Mental Disorders, nonpsychotic episode, antipsychotic, Mood Disorder, psychotic disorder Read More

• Inclusion Criteria:

  • Are 18 to 55 years of age, inclusive, at the time of informed consent with a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR™) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation
  • Have received a single, trial-approved SSRI or SNRI at an adequate dose for ≥ 6 weeks prior to screening
  • Have a treatment history of inadequate ADT response to at least one ADT (but not > 3) for the current episode. The current major depressive episode must be ≥ 6 weeks in duration. (An inadequate ADT response is defined as < 50% reduction in depressive symptom severity, as measured by subject self-report on the MGH-ATRQ.)

  • To be eligible for this trial

    • Have a MADRS Total Score of 20 or more at screening and the Phase A baseline, and have a MADRS Total Score of 18 or more at the Phase B baseline
    • Have no more than 20% improvement in MADRS Total Score at Phase B baseline compared to Phase A baseline
    • Have a score of 6 or more on the KSQ based on the Well being and Reversal Distress Anger-hostility subscales at screening, Phase A baseline, and Phase B baseline
    • Have anger attacks as documented by the AAQ at screening, Phase A baseline, and Phase B baseline
  • Are right-handed (defined according to the Edinburgh Handedness Inventory) and have normal hearing and normal/corrected-to-normal vision
  • Are willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period
  • Eligibility confirmed through a telephone SAFER interview with the subject and an independent expert centralized rater

• Exclusion Criteria:

  • Have a current need for involuntary commitment or have been hospitalized within 4 weeks of screening for the current major depressive episode
  • Have a current DSM-IV-TR Axis I diagnosis of any of the following: delirium, dementia, amnestic, or other cognitive disorders; schizophrenia, schizoaffective disorder, or other psychotic disorders; bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified; eating disorders (including anorexia nervosa or bulimia); obsessive compulsive disorder; panic disorder; or post-traumatic stress disorder
  • Have any of the following current Axis II DSM-IV-TR diagnoses: borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorders, or mental retardation
  • Experiencing hallucinations, delusions, or any psychotic symptomatology in the current major depressive episode