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A Placebo-Controlled Study of Mirtazapine for PTSD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302107
First Posted: March 13, 2006
Last Update Posted: November 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: January 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00302107     History of Changes
Obsolete Identifiers: NCT00449189
Other Study ID Numbers: MHBA-019-05F
First Submitted: March 9, 2006
First Posted: March 13, 2006
Results First Submitted: January 3, 2014
Results First Posted: November 26, 2014
Last Update Posted: November 26, 2014