Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT00876343|
Recruitment Status : Completed
First Posted : April 6, 2009
Results First Posted : February 10, 2014
Last Update Posted : February 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Aripiprazole (Fixed dose) Drug: Aripiprazole (Titrated dose) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||586 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Placebo-Controlled, Double-Blind, Parallel Group-Comparison Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Drug: Aripiprazole (Fixed dose)
administered orally once daily, 3 mg daily, 6 weeks
Other Name: Aripiprazole
Drug: Aripiprazole (Titrated dose)
administered orally once daily, 3 to 15 mg daily, 6 weeks
Other Name: Aripiprazole
Placebo Comparator: 3
administered orally once daily, 6 weeks
Other Name: Placebo of aripiprazole
- Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration ]
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
- MADRS Response Rate [ Time Frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration ]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).
- Mean Change in Sheehan Disability Scale (SDISS) [ Time Frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876343
|Chubu Region, Japan|
|Chugoku Region, Japan|
|Hokkaido Region, Japan|
|Kanto region, Japan|
|Kinki Region, Japan|
|Kyushu Region, Japan|
|Shikoku Region, Japan|
|Tohoku Region, Japan|
|Study Director:||Katsuhisa Saito||OPC-J|