Back to resultsAripiprazole Augmentation of Antidepressants in PTSD
Primary Purpose
PTSD
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring PTSD, Antidepressant, Aripiprazole, OEF, OIF
Eligibility Criteria
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
Sites / Locations
- Durham VAMC 508 Fulton Street
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aripiprazole
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Clinician Administered PTSD Scale (CAPS)
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)
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)
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
Connor-Davidson Resilience Scale (CD-RISC)
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)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00489866
Brief Title
Aripiprazole Augmentation of Antidepressants in PTSD
Official Title
Aripiprazole Augmentation of Antidepressants in PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durham VA Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, Antidepressant, Aripiprazole, OEF, OIF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aripiprazole
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Same as active drug.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
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.
Time Frame
Week 2 and Week 6
Title
Brief Assessment of Cognition in Affective Disorders (BAC-A)
Description
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).
Time Frame
Week 2 and Week 6
Title
Positive and Negative Symptoms Scale (PANSS)
Description
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)
Time Frame
Week 2 and Week 6
Secondary Outcome Measure Information:
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
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).
Time Frame
Week 2 and Week 6
Title
Beck Depression Inventory, Second Edition (BDI-II)
Description
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).
Time Frame
Week 2 and Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine E Marx, MD, MA
Organizational Affiliation
Durham VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VAMC 508 Fulton Street
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
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Aripiprazole Augmentation of Antidepressants in PTSD
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