PTSD
Conditions
Keywords
PTSD, Antidepressant, Aripiprazole, OEF, OIF
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.
Interventions
DRUGAripiprazole
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
DRUGPlacebo
Same as active drug.
Sponsors
Durham VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited for participation from 4/07 through 12/08. The study was closed to enrollment on 12/08.
Pre-assignment details
This was a randomized, placebo-controlled study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| Placebo Identical to Aripiprazole | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Aripiprazole | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Continuous | 31.49 years STANDARD_DEVIATION 2.64 | 36.14 years STANDARD_DEVIATION 5.52 | 33.81 years STANDARD_DEVIATION 11.26 |
| Region of Enrollment United States | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 7 | 6 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
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).
Time frame: Week 2 and Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTSD Symptoms Aripiprazole Treated Group | Brief Assessment of Cognition in Affective Disorders (BAC-A) | -0.41 Units on a Scale | Standard Deviation 1.23 |
| PTSD Symptoms Placebo Treated Group | Brief Assessment of Cognition in Affective Disorders (BAC-A) | -0.14 Units on a Scale | Standard Deviation 0.56 |
Primary
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.
Time frame: Week 2 and Week 6
Population: Analysis was intention to treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTSD Symptoms Aripiprazole Treated Group | Clinician Administered PTSD Scale (CAPS) | 18.6 Units on a scale | Standard Deviation 24.28 |
| PTSD Symptoms Placebo Treated Group | Clinician Administered PTSD Scale (CAPS) | 9.58 Units on a scale | — |
Primary
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)
Time frame: Week 2 and Week 6
Population: Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTSD Symptoms Aripiprazole Treated Group | Positive and Negative Symptoms Scale (PANSS) | 2.57 Units on a Scale | Standard Deviation 12.04 |
| PTSD Symptoms Placebo Treated Group | Positive and Negative Symptoms Scale (PANSS) | -5.1 Units on a Scale | Standard Deviation 7.31 |
Secondary
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).
Time frame: Week 2 and Week 6
Population: Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTSD Symptoms Aripiprazole Treated Group | Beck Depression Inventory, Second Edition (BDI-II) | 8.0 Units on a Scale | Standard Deviation 19.66 |
| PTSD Symptoms Placebo Treated Group | Beck Depression Inventory, Second Edition (BDI-II) | 2.28 Units on a Scale | Standard Deviation 12.12 |
Secondary
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).
Time frame: Week 2 and Week 6
Population: Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTSD Symptoms Aripiprazole Treated Group | Connor-Davidson Resilience Scale (CD-RISC) | -3.00 Units on a scale | Standard Deviation 28.27 |
| PTSD Symptoms Placebo Treated Group | Connor-Davidson Resilience Scale (CD-RISC) | -2.03 Units on a scale | Standard Deviation 7.79 |