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| ID | Type | Description | Link |
|---|---|---|---|
| 4304-02-12 | Other Identifier | Duke IRB# |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Massachusetts General Hospital | OTHER |
Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD. However, although these interventions can be helpful, many patients remain symptomatic despite initial treatment. In this study, we will examine the relative efficacy of the addition of paroxetine-CR compared to placebo for patients remaining symptomatic despite a brief and intensive course of cognitive-behavioral therapy (CBT).
This is a systematic controlled study examining the use of augmentation with pharmaotherapy for PTSD patients remaining symptomatic despite CBT (exposure therapy). The aims of the study include examination of: (1) the efficacy of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (2) the tolerability of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (3) the outcome of patients at 6 months follow-up to randomized treatment. Patients will initially have intensive (8 sessions over 4 weeks) prolonged exposure therapy. Patients who remain symptomatic will be randomzied to receive either flexibly-dosed paroxetine-CR (12.5 mg/d - 62.5 mg/d) or placebo in conjunction with additional 5 sessions of prolonged exposure over 10 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral therapy and paroxetine-CR | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Short PTSD Rating Interview (SPRINT) | ||
| Davidson Trauma Scale (DTS) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions Severity Scale (CGI-S) | ||
| Clinical Global Impressions Improvement Scale (CGI-I) | ||
| Posttraumatic Diagnostic Scale (PDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Davidson, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Diego | San Diego | California | 92093 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18348595 | Derived | Simon NM, Connor KM, Lang AJ, Rauch S, Krulewicz S, LeBeau RT, Davidson JR, Stein MB, Otto MW, Foa EB, Pollack MH. Paroxetine CR augmentation for posttraumatic stress disorder refractory to prolonged exposure therapy. J Clin Psychiatry. 2008 Mar;69(3):400-5. doi: 10.4088/jcp.v69n0309. |
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| Beck Depression Inventory (BDI) |
| Quality of Life Enjoyment and Satisfaction Questionnaire/General Activities Subscale (Q-LES-Q/GA) |
| Sheehan Disability Scale (SDS) |
| Connor-Davidson Resilience Scale (CD-RISC) |
| Post-Traumatic Cognitions Inventory (PTCI) |
| Severity of Symptoms Scale (SOSS) |
| Pittsburgh Sleep Quality Index (PSQI) |
| World Assumptions Scale (WAS) |
| Mood-SR Lifetime |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19122 | United States |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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