A Placebo-Controlled Study of Mirtazapine for PTSD
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|ClinicalTrials.gov Identifier: NCT00302107|
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : November 26, 2014
Last Update Posted : November 26, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety PTSD||Drug: Mirtazapine Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||June 2012|
Active Comparator: Arm 1
Mirtazapine initiated at 15mg qhs and titrated in 15mg increments to a maximum of 45 mg qhs as tolerated.
Other Name: Remeron
Placebo Comparator: Arm 2
Look-a-like placebo tablets under double-blind conditions
- 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. ]Structured Interview of Posttraumatic Stress Disorder (SIP) is a 17-item clinician-administered scale for PTSD based on Diagnostic Statistical Manual-IV criteria. The SIP has excellent test-retest reliability (0.89; p=.00001), and internal consistency (Conbach α of 0.80). The SIP showed significant correlations with the DTS (r=0.67, p=.0001) and the Impact of Event Scale (r=0.49 p=.0001). Relative to the SCID diagnosis of PTSD, sensitivity, specificity, positive predictive value, negative predictive value, and efficiency values were 100% for all indices using a score of 20 on the SIP. Items are scored on a scale from 0-4 which are summed to yield a total score ranging from 0 to 68 (higher score means more symptomatic or worse outcome). A symptom is counted as positive if it is at least a 2 (moderate).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302107
|United States, Alabama|
|Tuscaloosa, Alabama, United States, 35405|
|Principal Investigator:||Lori L Davis, MD AB||Tuscaloosa VAMC|