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Sponsored by: |
Tuscaloosa Research & Education Advancement Corporation |
Information provided by: | Tuscaloosa Research & Education Advancement Corporation |
ClinicalTrials.gov Identifier: | NCT00449189 |
The primary objective is to evaluate the efficacy and tolerability of mirtazapine (Remeron) in the treatment of PTSD. Primary Hypothesis to be tested: Veterans with PTSD will have improvement in their symptomatology after 8 weeks of treatment with mirtazapine compared to those treated with placebo. After completion of the placebo-controlled phase, patients who agree to continue in the study will be treated with open-label mirtazapine for an additional 8 weeks.
Condition | Intervention | Phase |
PTSD |
Drug: Mirtazapine Drug: Placebo |
Phase IV |
Drug Information available for: | Mirtazapine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans |
Estimated Enrollment: | 100 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Placebo: Placebo Comparator
Placebo vs. Mirtazapine
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Drug: Placebo
Placebo vs. Mirtazapine
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Mirtazapine: Active Comparator
Mirtazapine vs. Placebo
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Drug: Mirtazapine
Mirtazapine vs. placebo
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After meeting inclusion criteria, the patients enter an 8-week randomized, double-blind, placebo-controlled treatment trial of mirtazapine. After completion of the placebo-controlled phase, patients may continue study participation in an open-label mirtazapine for an additional 8 weeks.
The VA Pharmacy has an established working relationship with the investigators. The pharmacist maintains the randomization log and verifies the order for the placebo or mirtazapine (15mg) in look-a-like capsules. The investigators and patients are kept blind to the contents of the capsules until the end of the entire study. See procedure grid in attached Work Proposed Section attached. Based on symptomology and occurrence of side effects, the investigator increases the medication in 15 mg (one capsule) increments every week, as tolerated, until a maximum therapeutic benefit is achieved, not to exceed 45 mg/day (3 capsules). The dosing is at bedtime. Compliance is assessed by biweekly pill count. 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. At the end of the placebo-controlled phase, if the patients agree to continue in the study (confirmed at every visit) and they have not experienced an intolerable side effect related to the study medication, the patient will stop the placebo-controlled medication and begin open label mirtazapine, starting with 15mg at bedtime and titrating as tolerated to a maximum of 60mg/day.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lori L Davis, MD | (205) 554-3819 | Lori.Davis@va.gov |
Contact: Jason Newell, PhD | (205) 554-2000 ext 3574 | Jason.Newell@va.gov |
United States, Alabama | |||||
Tuscaloosa VA Medical Center | Recruiting | ||||
Tuscaloosa, Alabama, United States, 35404 | |||||
Principal Investigator: Lori L Davis, MD |
Tuscaloosa Research & Education Advancement Corporation |
Principal Investigator: | Lori L. Davis, MD | Tuscaloosa VA Medical Center |
Responsible Party: | Tuscaloosa Research Education & Advancement Corporation ( Lori L. Davis, M.D.; Chief, Research Service ) |
Study ID Numbers: | 0065 |
First Received: | March 16, 2007 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00449189 |
Health Authority: | United States: Institutional Review Board |
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