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A Placebo-Controlled Study of Mirtazapine for PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00302107
First received: March 9, 2006
Last updated: November 25, 2014
Last verified: November 2014
Results First Received: January 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Anxiety
PTSD
Interventions: Drug: Mirtazapine
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
Participants were recruited from the Tuscaloosa and Birmingham VA Medical Centers between April 2006 and November 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, participants signed informed consent, were assessed to have met eligibility criteria including free of psychotropic medications for the previous two weeks (4 weeks for fluoxetine) prior to randomization.

Reporting Groups
  Description
Mirtazapine Mirtazapine up to 45mg/qhs (three 15mg pills) as tolerated.
Placebo Placebo up to three pills qhs

Participant Flow:   Overall Study
    Mirtazapine     Placebo  
STARTED     39     39  
COMPLETED     31     30  
NOT COMPLETED     8     9  
Lost to Follow-up                 6                 5  
Protocol Violation                 1                 0  
Relocation                 0                 1  
Withdrawal by Subject                 0                 3  
Adverse Event                 1                 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.
Seventy-three (94%) were male; mean age 38.1 +/- 9.5 (SD) years in placebo group and 37.7 +/- 10.3 (SD) in mirtazapine group.

Reporting Groups
  Description
Mirtazapine Mirtazapine up to 45 mg/qhs as tolerated
Placebo Placebo up to three tablets qhs
Total Total of all reporting groups

Baseline Measures
    Mirtazapine     Placebo     Total  
Number of Participants  
[units: participants]
  39     39     78  
Age  
[units: years]
Mean ± Standard Deviation
  37.7  ± 10.3     38.1  ± 9.5     37.9  ± 9.9  
Gender  
[units: participants]
     
Female     2     3     5  
Male     37     36     73  
Region of Enrollment  
[units: participants]
     
United States     39     39     78  



  Outcome Measures

1.  Primary:   Structured Interview of Posttraumatic Stress Disorder (SIP)   [ Time Frame: Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score. ]


  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
Small sample of predominantly male combat veterans limits generalizability of findings.


  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: Lori Davis, MD
Organization: Tuscaloosa VA Medical Center
phone: 205-554-2000
e-mail: lori.davis@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00302107     History of Changes
Other Study ID Numbers: MHBA-019-05F
Study First Received: March 9, 2006
Results First Received: January 3, 2014
Last Updated: November 25, 2014
Health Authority: United States: Federal Government