Phase 3
N=349
A Study of Aripiprazole in Patients With Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00105196 ↗Enrolled (actual)
349
Serious AEs
0.6%
Results posted
May 2009
Primary outcome: Primary: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) — -10.12; -6.39 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole+ ADT (Drug); Placebo+ ADT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) |
-10.12; -6.39 | <0.001 sig |
| SECONDARY Mean Change in Sheehan Disability Scale (SDS) Mean Score |
-1.22; -0.80 | 0.075 |
| SECONDARY Mean Change in SDS Item Score (Social Life) |
-1.18; -0.65 | 0.052 |
| SECONDARY Mean Change in SDS Item Score (Family Life) |
-1.39; -0.82 | 0.037 sig |
| SECONDARY Mean Change in SDS Item Score (Work/School) |
-0.75; -0.67 | 0.792 |
Summary
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.
Eligibility Criteria
Inclusion Criteria
- Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks in duration.
- Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials.
Data sourced from ClinicalTrials.gov (NCT00105196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.