NCT00095745
Completed
Phase 3
A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country1,002 target enrollmentSeptember 2004
ConditionsMajor Depressive Disorder
InterventionsAntidepressant + Aripiprazole
Overview
- Phase
- Phase 3
- Intervention
- Antidepressant + Aripiprazole
- Conditions
- Major Depressive Disorder
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 1002
- Locations
- 1
- Primary Endpoint
- Safety assessments
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women, 18 years or older
- •Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
- •Treatment history of an inadequate response to at least one and no more than four antidepressants
Exclusion Criteria
- Not provided
Arms & Interventions
Antidepressant + Aripiprazole
Intervention: Antidepressant + Aripiprazole
Outcomes
Primary Outcomes
Safety assessments
Time Frame: throughout the study
Study Sites (1)
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