Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Completed · Phase 4 · Has a placebo group
Conditions studied: Stress Disorders, Post-Traumatic
In brief
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.
Key facts
- Study ID
- NCT00560612
- Run by
- Durham VA Medical Center
- People needed
- 12
- Starts
- 2006-01-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2019-06-18
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Durham VAMC — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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