Study of Mirtazapine for Post-Traumatic Stress Disorder (PTSD) in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans and Veterans From All Other Southwest Conditions
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 mirtazapine for the treatment of PTSD as defined on the Clinical Assessment of PTSD Scale (CAPS).
Methodology: After signing an informed consent and meeting all inclusion/exclusion criteria, the patient is randomized to either mirtazapine versus placebo for 8-week duration. During the study a pharmacist maintains the randomization log and verifies the order for the placebo or mirtazapine in look-a-like tablets. Patients' symptoms, side effects and compliance are assessed bi-weekly. Based on symptomology and occurrence of side effects, the investigator increases the medication in 15 mg increments, as tolerated, until a maximum therapeutic benefit is achieved, not to exceed 45 mg/day. The dosing is at bedtime. Compliance is assessed by bi-weekly pill count at week 4 and week 8. Patients are given supportive clinical management during the clinic visits. An investigator is available by telephone 24 hrs a day in case of emergency. Patients may be seen more often if needed. Efficacy will be measured by the following assessment scales: Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Scale (Ham-A), Clinical Global Impression Severity of Illness (CGI-s), Clinical Global Impression of Improvement (CGI-I), Global Assessment of Functioning (GAF), CAPS, Treatment Outcome PTSD rating scale (TOP-8), and Davidson Trauma Scale (DTS).
Clinical Significance: Mirtazapine has shown promise in treating PTSD in an open label trial. This study is the next step in proving mirtazapine's efficacy in treatment of PTSD.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans|
- Efficacy of drug versus placebo for treatment of PTSD [ Time Frame: Primary outcome is measured at baseline, week 8, week 16 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1
Mirtazapine vs. placebo
Placebo Comparator: Arm 2
Mirtazapine vs. placebo
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|United States, Alabama|
|Tuscaloosa, Alabama, United States, 35405|
|Principal Investigator:||Lori Lynne Davis, MD AB||Tuscaloosa VAMC|