Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post-Traumatic Stress Disorder (PTSD) Remaining Symptomatic After Initial Exposure Therapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stress Disorders, Post-Traumatic
- Sponsor
- Duke University
- Enrollment
- 17
- Locations
- 4
- Primary Endpoint
- Short PTSD Rating Interview (SPRINT)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of PTSD as defined by DSM-IV criteria
- •Patients must have remained symptomatic (CGI-S \> or = 3) and a score of at least 6 on the SPRINT after a minimum of 7 sessions of prolonged exposure (delivered within 6 weeks) to be eligible for randomized treatment.
Exclusion Criteria
- •Serious medical illness or instability for which hospitalization may be likely within the next 3 months
- •Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception
- •Concurrent use of other psychotropic medications
- •Lifetime diagnosis of schizophrenia or any other psychotic disorder, mental retardation, organic mental disorders, or bipolar disorder
- •Obsessive-Compulsive Disorder, eating disorders, or alcohol/substance abuse disorders within the last 6 months
- •A current primary diagnosis of major depression, dysthymia, social anxiety disorder, and generalized anxiety disorder
- •A history of hypersensitivity or poor response to paroxetine or those using antidepressants, buspirone, or beta-blockers within 2 weeks of randomization
- •Concurrent dynamic or supportive psychotherapy if started within 2 months prior to onset of study entry
Outcomes
Primary Outcomes
Short PTSD Rating Interview (SPRINT)
Davidson Trauma Scale (DTS)
Secondary Outcomes
- Clinical Global Impressions Severity Scale (CGI-S)
- Clinical Global Impressions Improvement Scale (CGI-I)
- Posttraumatic Diagnostic Scale (PDS)
- 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