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| ID | Type | Description | Link |
|---|---|---|---|
| 5816-05-4R1 | Other Identifier | Duke legacy protocol ID |
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| Name | Class |
|---|---|
| Janssen Pharmaceuticals | INDUSTRY |
The purpose of this study is to (1) compare the response of civilians with Posttraumatic Stress Disorder(PTSD) currently receiving sertraline without an optimal response to risperidone augmentation vs. placebo, and (2) to evaluate the tolerability of risperidone augmentation, and (3) to identifiy predictors of response to risperidone augmentation. the hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and effective.
This is a multi-center, two-phase study to evaluate the efficacy and safety of risperidone augmentation to sertraline treatment of Post-Traumatic Stress Disorder (PTSD). In the first phase, all patients will be assigned to take open label sertraline for 8 weeks (up to 200 mg/d). Those who have not achieved a significant decrease in their PTSD symptoms by week 8 will be entered into the second phase. In the second phase, patients will continue with the sertraline, but will then be randomly given either risperidone (up to 3 mg/d) or matching placebo in double-blind fashion.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline and risperidone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) |
| Measure | Description | Time Frame |
|---|---|---|
| Davidson Trauma Scale (DTS) | ||
| Beck Depression Inventory | ||
| Quality of Life/Q-LES-Q |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Davidson, M.D. | Duke University | Principal Investigator |
| Barbara Rothbaum, Ph.D. | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Medical Center | Atlanta | Georgia | 30322 | United States | ||
| Medical University of South Carolina |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Connor-Davidson Resilience Scale |
| Clinical Global Improvement Scale (CGI-I) |
| Positive and Negative Symptoms Scale (PANSS) |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |