Overview

This trial is active, not recruiting.

Condition ptsd
Treatments aripiprazole, placebo
Phase phase 2
Sponsor Durham VA Medical Center
Start date March 2007
End date September 2008
Trial size 14 participants
Trial identifier NCT00489866, VA IRB#01163

Summary

The proposed investigation will determine the therapeutic potential of aripiprazole augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans with PTSD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
aripiprazole
Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
(Placebo Comparator)
placebo
Same as active drug.

Primary Outcomes

Measure
Clinician Administered PTSD Scale (CAPS)
time frame: Week 2 and Week 6
Brief Assessment of Cognition in Affective Disorders (BAC-A)
time frame: Week 2 and Week 6
Positive and Negative Symptoms Scale (PANSS)
time frame: Week 2 and Week 6

Secondary Outcomes

Measure
Connor-Davidson Resilience Scale (CD-RISC)
time frame: Week 2 and Week 6
Beck Depression Inventory, Second Edition (BDI-II)
time frame: Week 2 and Week 6

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Outpatient veterans with posttraumatic stress disorder (PTSD) - Receiving treatment with an antidepressant at a stable dose for 4 weeks - Male or female - Ages 18-65 years old

Additional Information

Official title Aripiprazole Augmentation of Antidepressants in PTSD
Principal investigator Christine E Marx, MD, MA
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Durham VA Medical Center.