Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post-Traumatic Stress Disorder (PTSD) Remaining Symptomatic After Initial Exposure Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215163
• Other study ID #: 4304
• Secondary ID: 4304-02-12
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 20, 2005
• Last updated: May 29, 2013
• Start date: December 2002
• Est. completion date: June 2006

Study information

• Verified date: September 2005
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Cognitive-behavioral therapy and paroxetine-CR

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California at San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	GlaxoSmithKline, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short PTSD Rating Interview (SPRINT)
Primary	Davidson Trauma Scale (DTS)
Secondary	Clinical Global Impressions Severity Scale (CGI-S)
Secondary	Clinical Global Impressions Improvement Scale (CGI-I)
Secondary	Posttraumatic Diagnostic Scale (PDS)
Secondary	Beck Depression Inventory (BDI)
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire/General Activities Subscale (Q-LES-Q/GA)
Secondary	Sheehan Disability Scale (SDS)
Secondary	Connor-Davidson Resilience Scale (CD-RISC)
Secondary	Post-Traumatic Cognitions Inventory (PTCI)
Secondary	Severity of Symptoms Scale (SOSS)
Secondary	Pittsburgh Sleep Quality Index (PSQI)
Secondary	World Assumptions Scale (WAS)
Secondary	Mood-SR Lifetime