Aripiprazole Augmentation of Antidepressants in PTSD
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|ClinicalTrials.gov Identifier: NCT00489866|
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : March 28, 2012
Last Update Posted : March 31, 2015
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Drug: Aripiprazole Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Aripiprazole Augmentation of Antidepressants in PTSD|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||December 2014|
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.
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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)
- Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: 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) [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|