Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)

This study has been completed.

Sponsor:

Information provided by:

Durham VA Medical Center

ClinicalTrials.gov Identifier:

NCT00560612

First received: November 19, 2007

Last updated: March 31, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 19, 2007

Last Updated Date

March 31, 2011

Start Date ^ICMJE

January 2006

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).

A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.

Original Primary Outcome Measures ^ICMJE

The primary outcome will be improvement in PTSD symptoms as determined by the Clinician Administered PTSD Scale (CAPS). [ Time Frame: 12 weeks ]

Change History

Complete list of historical versions of study NCT00560612 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Short PTSD Rating Interview [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
8 questions rated on 0-4 scale (0=not at all; 4=very much). One question assesses how much better the subject feels since beginning treatment (0-100; 0= no change; 100= very much change). Final question assesses how much symptoms have improved since starting treatment (forced choice: worse; no change; minimally; much; very much).

Total score is computed from questions #1-8 (range=0-32).
Connor Davidson Resilience Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Separate depression and anxiety scores are determined from this measure. Possible ranges for both depression and anxiety scores: 0-21. 0-7 (normal); 8-10 (borderline abnormal); 11-21 (abnormal).
Clinical Global Impressions of Severity and of Improvement Scales [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The severity of illness is rated on a scale of 1-7; 1 being normal and 7 being among the most extremely ill patients.

Global improvement is similarly rated on a scale of 1-7; 1 being very much improved and 7 being very much worse.
Symptom Checklist 90 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Individual symptom scales are determined (via computer scoring) as follows:

SOM - Somatization O-C - Obsessive-Compulsive I-S - Interpersonal Sensitivity DEP - Depression ANX - Anxiety HOS - Hostility PHOB - Phobic Anxiety PAR - Paranoid Ideation PSY - Psychoticism

Global Indices Global Severity Index (GSI): Designed to measure overall psychological distress.

Positive Symptom Distress Index (PSDI): Designed to measure the intensity of symptoms.

Positive Symptom Total (PST): Reports number of self-reported symptoms.
Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Rates the following (scale 1-10; 1= not at all, 10=extremely) Work, Social Life, Family Life/Home Responsibilities.

Perceived Stress and Social Supports Scale (scale 1-10; 1= not at all, 10=extremely) Perceived stress, perceived social support

Original Secondary Outcome Measures ^ICMJE

Short PTSD Rating Interview, the Clinical Global Impressions of Severity and of Improvement Scales, Hospital Anxiety and Depression Scale, Connor Davidson Resilience Scale, the Symptom Checklist 90, and Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)

Official Title ^ICMJE

Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)

Brief Summary

The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.

Detailed Description

See brief summary

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Stress Disorders, Post-Traumatic

Intervention ^ICMJE

Drug: Paroxetine
Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
Drug: Placebo
Placebo: same as paroxetine (active comparator)

Study Arm (s)

Active Comparator: Paroxetine
Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.

Intervention: Drug: Paroxetine
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Veterans 18-55 years of age
Diagnosis of subthreshold PTSD (at least one symptom in PTSD symptom clusters B, C, and D by structured interview; with or without functional impairment exposure to war zone stressors)
Written informed consent; and
A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria:

Lifetime history of DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
History of substance dependence within the last 3 months
Significant suicide risk or serious suicide attempt within the last year
Clinically significant medical condition or laboratory or EKG abnormality
Women of childbearing potential who are unwilling to practice an acceptable method of contraception
Subjects needing concurrent use of psychiatric medications
History of hypersensitivity to paroxetine
HADS depression subscale score > 12
Failure to respond to an adequate trial of paroxetine (20 mg/day x 8 wks).

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00560612

Other Study ID Numbers ^ICMJE

VA IRB# 00993

Has Data Monitoring Committee

Not Provided

Responsible Party

Christine E. Marx, MD, Durham Veterans Affairs Medical Center

Study Sponsor ^ICMJE

Durham VA Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christine E Marx, MD, MA

Durham VAMC

Information Provided By

Durham VA Medical Center

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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