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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paroxetine

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

Group Type ACTIVE_COMPARATOR

Paroxetine

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo: same as paroxetine (active comparator)

Interventions

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Paroxetine

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

Intervention Type DRUG

Placebo

Placebo: same as paroxetine (active comparator)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Veterans 18-55 years of age
2. 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)
3. Written informed consent; and
4. A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No