To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder (MDD)

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be 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 subjects who have completed participation in Protocol 31-08-255, 31-08-256, or 31-08-263 ("rollover" subjects).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aripiprazole; Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• Subjects who participated in Protocol 31-08-255, 31-08-256, or 31-08-263.

Exclusion Criteria:

• Subjects with a current need for involuntary commitment or who have been hospitalized ≤ 28 days of the Baseline Visit for the current major depressive episode.

• Subjects 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.

• Subjects with a diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

• Subjects experiencing hallucinations, delusions, or any psychotic symptomatology in the current depressive episode.

• Subjects who have met 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. Subjects with two positive drug results for cocaine should be excluded from the study.

• Subjects with hypothyroidism or hyperthyroidism.

• Subjects with a significant risk of committing suicide based on history, investigator's judgment, and/or evaluation based on the C-SSRS

• Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.

• Subjects with insulin-dependent diabetes mellitus (IDDM).

• Subjects with epilepsy or significant history of seizure disorders, except for a single childhood febrile seizure, post-traumatic, etc.