Trial Outcomes & Findings for Aripiprazole Augmentation of Antidepressants in PTSD (NCT NCT00489866)
NCT ID: NCT00489866
Last Updated: 2015-03-31
Results Overview
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.
COMPLETED
PHASE2
14 participants
Week 2 and Week 6
2015-03-31
Participant Flow
Subjects were recruited for participation from 4/07 through 12/08. The study was closed to enrollment on 12/08.
This was a randomized, placebo-controlled study.
Participant milestones
| Measure |
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
|
Placebo
Identical to Aripiprazole
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aripiprazole Augmentation of Antidepressants in PTSD
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=7 Participants
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
n=7 Participants
Identical to Aripiprazole
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.49 years
STANDARD_DEVIATION 2.64 • n=5 Participants
|
36.14 years
STANDARD_DEVIATION 5.52 • n=7 Participants
|
33.81 years
STANDARD_DEVIATION 11.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 2 and Week 6Population: Analysis was intention to treat.
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.
Outcome measures
| Measure |
PTSD Symptoms Aripiprazole Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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.
|
PTSD Symptoms Placebo Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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.
|
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS)
|
18.6 Units on a scale
Standard Deviation 24.28
|
9.58 Units on a scale
Standard Deviation 11.
|
PRIMARY outcome
Timeframe: Week 2 and Week 6The 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).
Outcome measures
| Measure |
PTSD Symptoms Aripiprazole Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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.
|
PTSD Symptoms Placebo Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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)
|
-0.41 Units on a Scale
Standard Deviation 1.23
|
-0.14 Units on a Scale
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: Week 2 and Week 6Population: Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.
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)
Outcome measures
| Measure |
PTSD Symptoms Aripiprazole Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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.
|
PTSD Symptoms Placebo Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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.
|
|---|---|---|
|
Positive and Negative Symptoms Scale (PANSS)
|
2.57 Units on a Scale
Standard Deviation 12.04
|
-5.1 Units on a Scale
Standard Deviation 7.31
|
SECONDARY outcome
Timeframe: Week 2 and Week 6Population: Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.
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).
Outcome measures
| Measure |
PTSD Symptoms Aripiprazole Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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.
|
PTSD Symptoms Placebo Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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.
|
|---|---|---|
|
Connor-Davidson Resilience Scale (CD-RISC)
|
-3.00 Units on a scale
Standard Deviation 28.27
|
-2.03 Units on a scale
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: Week 2 and Week 6Population: Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.
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).
Outcome measures
| Measure |
PTSD Symptoms Aripiprazole Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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.
|
PTSD Symptoms Placebo Treated Group
n=7 Participants
The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores 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.
|
|---|---|---|
|
Beck Depression Inventory, Second Edition (BDI-II)
|
8.0 Units on a Scale
Standard Deviation 19.66
|
2.28 Units on a Scale
Standard Deviation 12.12
|
Adverse Events
Aripiprazole
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole
n=7 participants at risk
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
n=7 participants at risk
Identical to Aripiprazole
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Restlessness
|
28.6%
2/7 • Number of events 2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Increased Motor
|
0.00%
0/7
|
42.9%
3/7 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Decreased Motor Activity
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Malaise
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Drowsiness
|
28.6%
2/7 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Cramps
|
14.3%
1/7 • Number of events 1
|
42.9%
3/7 • Number of events 3
|
|
General disorders
Tremor
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Vertigo
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Syncope
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Cold Extremity
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Dry Mouth
|
14.3%
1/7 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Nasal Congestion
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Blurred Vision
|
28.6%
2/7 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Constipation
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Sweating
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Nausea
|
0.00%
0/7
|
57.1%
4/7 • Number of events 4
|
|
General disorders
Vomiting
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Diarrhea
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Menstrual Disturbance
|
0.00%
0/7
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Decreased Interest in Sex
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Impaired sexual performance
|
28.6%
2/7 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Dermatological
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Joint Pain/Stiffness
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Join pain/stiffness
|
14.3%
1/7 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Decreased appetite
|
0.00%
0/7
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Increased appetite
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Headache
|
14.3%
1/7 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place