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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00302107 |
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 | Intervention | Phase |
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Anxiety PTSD |
Drug: Mirtazapine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans |
Estimated Enrollment: | 100 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Mirtazapine
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Drug: Mirtazapine
Mirtazapine vs. placebo
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2: Placebo Comparator
Placebo
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Drug: Placebo
Mirtazapine vs. placebo
|
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Beverly Whitfield, MA | (205) 554-2000 ext 2733 | beverly.whitfield@va.gov |
Contact: Sheila Essary, LPN | (205) 554-2000 ext 3277 | sheila.essary@va.gov |
United States, Alabama | |
Tuscaloosa VAMC | Recruiting |
Tuscaloosa, Alabama, United States, 35405 | |
Contact: Lori L Davis, AB MD (205) 554-3819 lori.davis@va.gov | |
Contact: Beatrix Haustein, MBA (205) 554-2000 ext 2840 beatrix.haustein@va.gov | |
Principal Investigator: Lori Lynne Davis, AB MD |
Principal Investigator: | Lori Lynne Davis, AB MD | Tuscaloosa VAMC |
Responsible Party: | Department of Veterans Affairs ( Davis, Lori - Principal Investigator ) |
Study ID Numbers: | MHBA-019-05F |
Study First Received: | March 9, 2006 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00302107 History of Changes |
Health Authority: | United States: Federal Government |
Mirtazapine PTSD Veterans antidepressant |
Neurotransmitter Agents Adrenergic Agents Psychotropic Drugs Stress Adrenergic alpha-Antagonists Mirtazapine Stress Disorders, Traumatic Antidepressive Agents, Tricyclic Histamine |
Anxiety Disorders Histamine Antagonists Mental Disorders Stress Disorders, Post-Traumatic Histamine H1 Antagonists Histamine phosphate Adrenergic Antagonists Antidepressive Agents |
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Histamine Agents Adrenergic alpha-Antagonists Mirtazapine Stress Disorders, Traumatic Pharmacologic Actions |
Antidepressive Agents, Tricyclic Anxiety Disorders Histamine Antagonists Mental Disorders Therapeutic Uses Stress Disorders, Post-Traumatic Histamine H1 Antagonists Adrenergic Antagonists Central Nervous System Agents Antidepressive Agents |