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

• ClinicalTrials.gov Identifier: NCT00560612
• Recruitment Status: Completed
• First Posted: November 20, 2007
• Results First Posted: January 25, 2011
• Last Update Posted: June 18, 2019
• Sponsor: Durham VA Medical Center
• Information provided by (Responsible Party): Durham VA Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stress Disorders, Post-Traumatic	Drug: Paroxetine; Drug: Placebo	Phase 4

Detailed Description:

See brief summary

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
• Study Start Date: January 2006
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Paroxetine; Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.	Drug: Paroxetine; Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
Placebo Comparator: Placebo	Drug: Placebo; Placebo: same as paroxetine (active comparator)

Outcome Measures

Primary Outcome Measures :

1. Change in Clinician Administered PTSD Scale (CAPS) Scores [ Time Frame: Change in Scores (12 weeks-Baseline) ]

   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.

Secondary Outcome Measures :

1. Change in Short PTSD Rating Interview Scores [ Time Frame: Change in Scores (12 weeks-Baseline) ]
   The SPRINT contains 8 questions which are rated on a 0-4 scale (0=not at all; 4=very much). The total score is computed from summing questions #1-8 (range=0-32). The higher the total score, the worse the symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.
2. Change in Connor Davidson Resilience Scale Scores [ Time Frame: Change in Scores (12 Weeks-Baseline) ]
   This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.
3. Change in Hospital Anxiety and Depression Scale Scores [ Time Frame: Change in Scores (12 Weeks-Baseline) ]
   The total HADS score is presented, which is regarded as a global measure of psychological distress. The total score ranges from 0-42. Each individual question is rated on a 4 point scale (0=absent to 3 =extreme presence). The higher the score, the greater level of psychological distress. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

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 VA Medical Center
• ClinicalTrials.gov Identifier: NCT00560612
• Other Study ID Numbers: VA IRB# 00993
• First Posted: November 20, 2007
• Results First Posted: January 25, 2011
• Last Update Posted: June 18, 2019
• Last Verified: May 2019

Keywords provided by Durham VA Medical Center:

PTSD; Paroxetine; Subthreshold

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Paroxetine; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors