Secondary Prevention With Paroxetine vs. Placebo in Subthreshold PTSD - Full Text View

Sponsored by:	Durham VA Medical Center
Information provided by:	Durham VA Medical Center
ClinicalTrials.gov Identifier:	NCT00560612

Purpose

The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold 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.

Condition	Intervention	Phase
Stress Disorders, Post-Traumatic	Drug: Paroxetine or Placebo	Phase IV

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Secondary Prevention With Paroxetine vs. Placebo in Subthreshold PTSD

Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:

The primary outcome will be improvement in PTSD symptoms as determined by the Clinician Administered PTSD Scale (CAPS). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Paroxetine or Placebo Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
2: Placebo Comparator	Drug: Paroxetine or Placebo Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.

Detailed Description:

See brief summary

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560612

Locations

United States, North Carolina
Durham VAMC
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Durham VA Medical Center

Investigators

Principal Investigator:

Christine E Marx, MD, MA

Durham VAMC

More Information

Responsible Party:	Durham Veterans Affairs Medical Center ( Christine E. Marx, MD )
Study ID Numbers:	VA IRB# 00993
Study First Received:	November 19, 2007
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00560612
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Durham VA Medical Center:

PTSD
Paroxetine
Subthreshold

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Neoplasm Metastasis
Stress Disorders, Post-Traumatic

Stress
Paroxetine
Serotonin
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Serotonin Uptake Inhibitors
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009