To Assess the 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: Aripiprazole; Escitalopram
Intervention description: Aripiprazole oral capsules; Escitalopram oral capsules
Intervention MeSH terms: Aripiprazole; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Group composed of eligible rollover participants who completed one of the previous studies: 31-08-255 [NCT01111539], 31-08-256 [NCT01111552], or 31-08-263 [NCT01111565]
Masking: None (Open Label)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression

Summary:

      This is a multicenter, 52-week, open-label study designed to assess the safety and
      tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with
      major depressive disorder (MDD). Enrollment into the study will be from eligible participants
      who have completed participation in Protocol 31-08-255 [NCT01111539], 31-08-256
      [NCT01111552], or 31-08-263 [NCT01111565] ("rollover" participants).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who participated in Protocol 31-08-255, 31-08-256, or 31-08-263.

        Exclusion Criteria:

          -  Participants with a current need for involuntary commitment or who have been
             hospitalized ≤ 28 days of the Baseline Visit for the current major depressive episode.

          -  Participants with a diagnosis of delirium, dementia, amnestic or other cognitive
             disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder,
             Bipolar I or II disorder, eating disorder (including anorexia nervosa or bulimia),
             obsessive compulsive disorder, panic disorder, or posttraumatic stress disorder.

          -  Participants with a diagnosis of borderline, antisocial, paranoid, schizoid,
             schizotypal or histrionic personality disorder.

          -  Participants experiencing hallucinations, delusions, or any psychotic symptomatology
             in the current depressive episode.

          -  Participants who have met Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for substance abuse in the past 6
             months (prior to the Baseline Visit) and/or dependence up to and including the past 12
             months (prior to the Baseline Visit), including alcohol and benzodiazepines, but
             excluding caffeine and nicotine. Participants with two positive drug results for
             cocaine should be excluded from the study.

          -  Participants with hypothyroidism or hyperthyroidism.

          -  Participants with a significant risk of committing suicide based on history,
             investigator's judgment, and/or evaluation based on the Columbia-Suicide Severity
             Rating Scale (C-SSRS).

          -  Participants who currently have clinically significant neurological, hepatic, renal,
             metabolic, hematological, immunological, cardiovascular, pulmonary, or
             gastrointestinal disorders.

          -  Participants with insulin-dependent diabetes mellitus (IDDM).

          -  Participants with epilepsy or significant history of seizure disorders, except for a
             single childhood febrile seizure, post-traumatic, etc.