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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 2 and Week 6 |
| 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). | Week 2 and 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) | Week 2 and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 2 and Week 6 |
| Beck Depression Inventory, Second Edition (BDI-II) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine E Marx, MD, MA | Durham VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VAMC 508 Fulton Street | Durham | North Carolina | 27705 | United States |
This was a randomized, placebo-controlled study.
Subjects were recruited for participation from 4/07 through 12/08. The study was closed to enrollment on 12/08.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Identical to Aripiprazole |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was intention to treat. | Posted | Mean | Standard Deviation | Units on a scale | Week 2 and Week 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | Systematic Assessment |
One of the primary limitations of this pilot clinical trial is small sample size. Results of this study will clearly need to be replicated in a larger cohort.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine E. Marx, MD | Durham VAMC | 9192860411 | 7426 | marx0001@mc.duke.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Placebo | Drug | Same as active drug. |
|
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). |
| Week 2 and Week 6 |
Identical to Aripiprazole |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | PTSD Symptoms Placebo Treated Group | 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. |
|
|
| 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). | Posted | Mean | Standard Deviation | Units on a Scale | Week 2 and Week 6 |
|
|
|
| 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) | Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized. | Posted | Mean | Standard Deviation | Units on a Scale | Week 2 and Week 6 |
|
|
|
| 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). | Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized. | Posted | Mean | Standard Deviation | Units on a scale | Week 2 and Week 6 |
|
|
|
| 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). | Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized. | Posted | Mean | Standard Deviation | Units on a Scale | Week 2 and Week 6 |
|
|
|
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | Placebo | Identical to Aripiprazole | 0 | 7 | 6 | 7 |
| Restlessness | Psychiatric disorders | Systematic Assessment |
|
| Increased Motor | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Decreased Motor Activity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Malaise | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Cramps | General disorders | Systematic Assessment |
|
| Tremor | General disorders | Systematic Assessment |
|
| Vertigo | General disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Cold Extremity | General disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Nasal Congestion | General disorders | Systematic Assessment |
|
| Blurred Vision | General disorders | Systematic Assessment |
|
| Constipation | General disorders | Systematic Assessment |
|
| Sweating | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment |
|
| Diarrhea | General disorders | Systematic Assessment |
|
| Menstrual Disturbance | General disorders | Systematic Assessment |
|
| Decreased Interest in Sex | General disorders | Systematic Assessment |
|
| Impaired sexual performance | General disorders | Systematic Assessment |
|
| Dermatological | General disorders | Systematic Assessment |
|
| Joint Pain/Stiffness | General disorders | Systematic Assessment |
|
| Join pain/stiffness | General disorders | Systematic Assessment |
|
| Decreased appetite | General disorders | Systematic Assessment |
|
| Increased appetite | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |