Aripiprazole Augmentation of Antidepressants in PTSD

Phase 2

Completed

• Conditions: PTSD
• Interventions: Drug: Placebo; Drug: Aripiprazole

• Registration Number: NCT00489866
• Lead Sponsor: Durham VA Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-21
• Primary Completion: 2008-09
• Results First Submitted: 2011-09-16
• Results First Submitted QC: 2012-02-28
• Results First Posted: 2012-03-28
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Aripiprazole	Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale (CAPS)	Week 2 and Week 6	Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).; A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
Brief Assessment of Cognition in Affective Disorders (BAC-A)	Week 2 and Week 6	The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6).
Positive and Negative Symptoms Scale (PANSS)	Week 2 and Week 6	The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6)

Secondary Outcome Measures

Name	Time	Method
Connor-Davidson Resilience Scale (CD-RISC)	Week 2 and Week 6	This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. Change scores calculated at Week 2 and Week 6 (Week 2 minus Week 6).
Beck Depression Inventory, Second Edition (BDI-II)	Week 2 and Week 6	The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression. Scores range from 0 to 63 (higher scores suggest higher levels of depression). Change scores were calculated from Week 2 and Week 6 scores (Week 2 minus Week 6).

Trial Locations

Locations (1)

Durham VAMC 508 Fulton Street; 🇺🇸 Durham, North Carolina, United States