Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

NCT00608543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2012-10-26

Study results available

Summary

Our target population will have been adequately treated with one of three selective serotonin reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks and continue to experience symptoms of depression that have prompted them to seek additional treatment. Escitalopram, citalopram, and sertraline were selected for use in this study because they are among the most commonly selected SSRIs and they are associated with a reduced likelihood of drug-drug interactions with aripiprazole. After completion of the screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15 mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician, in conjunction with study participation. Symptom severity will be assessed on a weekly basis, and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We hypothesize that aripiprazole augmentation will be associated with reductions in symptom severity, and with improved performance on measures of psychosocial and cognitive function.

Conditions

Major Depressive Disorder

Interventions

DRUG

Aripiprazole

varied dose (5, 10, 15 mg qd) for 6 wks

Sponsors & Collaborators

Bristol-Myers Squibb
collaborator INDUSTRY
University of Texas Southwestern Medical Center
lead OTHER

Study Design

Allocation: NA
Purpose: TREATMENT
Masking: NONE
Model: SINGLE_GROUP

Eligibility

Min Age: 18 Years
Max Age: 65 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2005-10-31
Primary Completion: 2009-01-31
Completion: 2009-01-31

Countries

United States

Study Locations

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Entities

Diseases

Major Depressive Disorder

Companies

Bristol-Myers Squibb