Phase 4 N=12 Randomized Quadruple-blind Prevention

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

Stress Disorders, Post-Traumatic

Bottom Line

View on ClinicalTrials.gov: NCT00560612 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2011

Primary outcome: Primary: Change in Clinician Administered PTSD Scale (CAPS) Scores — -3.40; -5.00 Units on a scale — p=0.7054

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Paroxetine (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Durham VA Medical Center
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Clinician Administered PTSD Scale (CAPS) Scores	-3.40; -5.00	0.7054
SECONDARY Change in Short PTSD Rating Interview Scores	-3.80; -2.00	0.4583
SECONDARY Change in Connor Davidson Resilience Scale Scores	-0.80; -1.29	0.7443
SECONDARY Change in Hospital Anxiety and Depression Scale Scores	-3.40; -0.17	0.065

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.

Eligibility 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).

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Data sourced from ClinicalTrials.gov (NCT00560612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.