Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Aripiprazole (Fixed dose); Drug: Aripiprazole (Titrated dose); Drug: Placebo

• Registration Number: NCT00876343
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-12
• Results First Submitted: 2013-12-20
• Results First Submitted QC: 2013-12-20
• Last Update Submitted: 2013-12-20
• Results First Posted: 2014-02-10
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

1. Patients who are either inpatients or outpatients
2. Patients who have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial
3. Patients diagnosed as having either "296.2x Major Depressive Disorder, Single Episode" or "296.3x Major Depressive Disorder, Recurrent" according to DSM-IV-TR, and for whom the current episode of major depressive disorder has been ongoing for more than 8 weeks
4. Patients with a HAM-D17 total score of 18 or more

Exclusion Criteria

1. Female patients of child bearing potential who wish to become pregnant during the treatment period, or within 4 weeks after study completion/discontinuation
2. Female patients who are pregnant, possibly pregnant, or breast feeding
3. Patients judged to be unable to tolerate any type of antidpressant treatment (including drugs not being used in the current episode of major depressive disorder), based on treatment history to date
4. Patients who have previously received electro-convulsive therapy
5. Patients who have participated in clinical studies on medical devices or other drugs within the past month
6. Patients at risk of having serious adverse events or developing symptoms that could interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia syndrome overlapping with symptoms of depression), based on previous medical history
7. Patients with a history or a complication of diabetes
8. Patients with thyroid disease (excluding patients who are stabilized on drug therapy for at least 3 months)
9. Patients with a history of serotonin syndrome or psychotropic neuroleptic malignant syndrome
10. Patients with a history of seizure disorder (epilepsy etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aripiprazole (Fixed dose)	Fixed dose
2	Aripiprazole (Titrated dose)	Titration dose
3	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	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

Secondary Outcome Measures

Name	Time	Method
MADRS Response Rate	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)	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).