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

This study has been completed.
Sponsor:
Information provided by:
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00560612
First received: November 19, 2007
Last updated: March 31, 2011
Last verified: March 2011
Results First Received: November 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Stress Disorders, Post-Traumatic
Interventions: Drug: Paroxetine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient enrollment at the Durham VA Medical Center occurred from February 2006 until July 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paroxetine

Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).

Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).

Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).

Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).

Week 12: Final study visit (no study medication dispensed).

Placebo Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).

Participant Flow:   Overall Study
    Paroxetine     Placebo  
STARTED     5     7  
COMPLETED     5     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paroxetine

Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).

Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).

Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).

Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).

Week 12: Final study visit (no study medication dispensed).

Placebo Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
Total Total of all reporting groups

Baseline Measures
    Paroxetine     Placebo     Total  
Number of Participants  
[units: participants]
  5     7     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     7     12  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  39.3  ± 4.73     35.9  ± 9.69     37.3  ± 7.9  
Gender  
[units: participants]
     
Female     1     1     2  
Male     4     6     10  
Region of Enrollment  
[units: participants]
     
United States     5     7     12  



  Outcome Measures

1.  Primary:   Clinician Administered PTSD Scale (CAPS)   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Short PTSD Rating Interview   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Connor Davidson Resilience Scale   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Hospital Anxiety and Depression Scale   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Clinical Global Impressions of Severity and of Improvement Scales   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Symptom Checklist 90   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Sheehan Disability Scale (SDS)   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Christine Marx, MD
Organization: Durham VA Medical Center
phone: 919 286-0411 ext 7426
e-mail: marx0001@mc.duke.edu


No publications provided


Responsible Party: Christine E. Marx, MD, Durham Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00560612     History of Changes
Other Study ID Numbers: VA IRB# 00993
Study First Received: November 19, 2007
Results First Received: November 30, 2010
Last Updated: March 31, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board