Aripiprazole Augmentation of Antidepressants in PTSD
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Aripiprazole Augmentation of Antidepressants in PTSD|
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
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) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]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) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]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)
- Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]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) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]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).
|Study Start Date:||March 2007|
|Study Completion Date:||December 2014|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489866
|United States, North Carolina|
|Durham VAMC 508 Fulton Street|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Christine E Marx, MD, MA||Durham VAMC|