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

NCT00560612 | Completed Phase 4 Results

• 1 other identifier: VA IRB# 00993
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD; Paroxetine; Subthreshold

Outcome Measures

Primary Outcomes (1)

• Change in Clinician Administered PTSD Scale (CAPS) Scores

  Mean change scores in posttraumatic stress disorder symptoms. Raw 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. The outcome measure is the change in scores before and after treatment. That is, the baseline and at 12 weeks difference scores.

  Change in Scores (12 weeks-Baseline)

Secondary Outcomes (3)

• Change in Short PTSD Rating Interview Scores

  Change in Scores (12 weeks-Baseline)

• Change in Connor Davidson Resilience Scale Scores

  Change in Scores (12 Weeks-Baseline)

• Change in Hospital Anxiety and Depression Scale Scores

  Change in Scores (12 Weeks-Baseline)

Study Arms (2)

Paroxetine

ACTIVE COMPARATOR

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

Drug: Paroxetine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Paroxetine DRUG

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

Paroxetine

Placebo DRUG

Placebo: same as paroxetine (active comparator)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (1)

Durham VAMC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Christine Marx, MD
• Organization: Durham VA Medical Center

marx0001@mc.duke.edu

919 286-0411

Study Officials

• Christine E Marx, MD, MA

  Durham VAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: January 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 18, 2019
• Results First Posted: January 25, 2011

Record last verified: 2019-05

Locations

US (1)