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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral therapy and paroxetine-CR
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, Anxiety, CBT, Exposure, Paroxetine, Paroxetine-CR

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California at San Diego
  • Massachusetts General Hospital
  • Duke University Medical Center
  • University of Pennsylvania

Outcomes

Primary Outcome Measures

Short PTSD Rating Interview (SPRINT)
Davidson Trauma Scale (DTS)

Secondary Outcome Measures

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

Full Information

First Posted
September 20, 2005
Last Updated
May 29, 2013
Sponsor
Duke University
Collaborators
GlaxoSmithKline, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00215163
Brief Title
Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy
Official Title
Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post-Traumatic Stress Disorder (PTSD) Remaining Symptomatic After Initial Exposure Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
GlaxoSmithKline, Massachusetts General Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
PTSD, Anxiety, CBT, Exposure, Paroxetine, Paroxetine-CR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cognitive-behavioral therapy and paroxetine-CR
Primary Outcome Measure Information:
Title
Short PTSD Rating Interview (SPRINT)
Title
Davidson Trauma Scale (DTS)
Secondary Outcome Measure Information:
Title
Clinical Global Impressions Severity Scale (CGI-S)
Title
Clinical Global Impressions Improvement Scale (CGI-I)
Title
Posttraumatic Diagnostic Scale (PDS)
Title
Beck Depression Inventory (BDI)
Title
Quality of Life Enjoyment and Satisfaction Questionnaire/General Activities Subscale (Q-LES-Q/GA)
Title
Sheehan Disability Scale (SDS)
Title
Connor-Davidson Resilience Scale (CD-RISC)
Title
Post-Traumatic Cognitions Inventory (PTCI)
Title
Severity of Symptoms Scale (SOSS)
Title
Pittsburgh Sleep Quality Index (PSQI)
Title
World Assumptions Scale (WAS)
Title
Mood-SR Lifetime

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Davidson, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18348595
Citation
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.
Results Reference
derived

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

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