Major Depressive Disorder
Conditions
Brief summary
This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder.
Interventions
Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women, 18-65 years old * Experienced a 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 antidepressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in a depression rating scale at endpoint | Baseline, Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change in a disability scale and Clinical Global Impression scale at endpoint | Baseline, Week 8 |
Countries
United States
Outcome results
None listed