Status:
COMPLETED
A Placebo-Controlled Study of Mirtazapine for PTSD
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Anxiety
PTSD
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief Summary
Objective: To study the efficacy and tolerability of mirtazapine (Remeron) in the treatment of PTSD. Research Design: This is an 8-week randomized, double-blind, placebo-controlled treatment trial of...
Detailed Description
Title: A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans and Veterans from all other Southwest Asia Conditions Sponsor of the study: VA Merit grant Research Setting: Subjects wi...
Eligibility Criteria
Inclusion
- Diagnosis of PTSD, confirmed by Mini-International Neuropsychiatric Interview (MINI) and CAPS
- Age 19 or older
- No substance abuse/dependence for the previous 4 weeks (except for nicotine and caffeine)
- Free of psychotropic medication for 2 weeks (except 4 weeks for fluoxetine)
- Clinically normal physical and laboratory examination (lab profile listed below). LFTs up to 2.5 times the normal limit will be allowed.
- Women of childbearing potential must be using medically approved methods of birth control (such as a condom, birth control pill, Depo-Provera, or diaphragm with spermicides)
- Signed informed consent
- Male or female, any race or ethnic origin
Exclusion
- Lifetime history of bipolar I, psychotic, or cognitive disorders
- Actively suicidal, homicidal, or psychotic
- History of sensitivity to mirtazapine
- Unstable general medical conditions
- Score 6 on Question #10 of MADRS regarding suicidal ideation
- Women who are pregnant, planning to become pregnant or breastfeed during the study
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00302107
Start Date
April 1 2006
End Date
June 1 2012
Last Update
November 26 2014
Active Locations (1)
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1
Tuscaloosa VAMC
Tuscaloosa, Alabama, United States, 35405