To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
586
administered orally once daily, 3 mg daily, 6 weeks
administered orally once daily, 3 to 15 mg daily, 6 weeks
administered orally once daily, 6 weeks
Unnamed facility
Chubu Region, Japan
Unnamed facility
Chugoku Region, Japan
Unnamed facility
Hokkaido Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The change in MADRS total score from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period by covariance analysis, and compared the aripiprazole variable dose group with the placebo group as well as the aripiprazole fixed dose group with the placebo group. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1\. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts
Time frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
MADRS Response Rate
The percentage of subjects with a decrease in MADRS total score of 50% or more, from the end of the SSRI/SNRI treatment period to the end of the placebo-controlled, double-blind treatment period (or withdrawal).
Time frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
Mean Change in Sheehan Disability Scale (SDISS)
The endpoint evaluated the change in SDISS from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period. The patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Time frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
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Kinki Region, Japan
Unnamed facility
Kyushu Region, Japan
Unnamed facility
Shikoku Region, Japan
Unnamed facility
Tohoku Region, Japan