Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram; Aripiprazole; Placebo
Intervention description: Escitalopram oral capsules.; Aripiprazole oral capsules.; Study drug matching placebo capsule.
Intervention MeSH terms: Aripiprazole; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression

Summary:

      This will be a multicenter, randomized, double-blind study designed to assess the efficacy,
      safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in
      participants with MDD who have demonstrated an incomplete response to a prospective trial of
      Escitalopram, and report a treatment history for the current MDD episode of an inadequate
      response to at least one and no more than three adequate trials of an approved antidepressant
      other than Escitalopram. An inadequate response is defined as less than a 50% reduction in
      depressive symptom severity as assessed by the participant's self-report on the Massachusetts
      General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the
      investigator as part of the participant's medical and psychiatric history. An adequate trial
      is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks
      for combination treatments) at an approved dose as specified in the ATRQ.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a current diagnosis of a major depressive episode. The current
             depressive episode must be ≥ 8 weeks in duration

          -  Participants willing to discontinue all prohibited psychotropic medication starting
             from the time of signing the informed consent and during the study period

          -  Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥
             18 at the Baseline Visit for the Prospective Treatment Phase.

        Exclusion Criteria:

          -  Lack of prior treatment with an antidepressant during the current depressive episode

          -  Participants who report treatment with adjunctive or monotherapy antipsychotic
             treatment during the current depressive episode.

          -  Participants experiencing hallucinations, delusions or any psychotic symptomatology in
             the current depressive episode

          -  Participants with epilepsy or significant history of seizure disorders

          -  Participants with a clinically significant current diagnosis of borderline,
             antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder

          -  Participants who have received electroconvulsive therapy (ECT) in the last 10 years.