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
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Purpose
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 |
|---|---|---|
|
Anxiety PTSD |
Drug: Mirtazapine Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 80 |
| Study Start Date: | April 2006 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Mirtazapine
|
Drug: Mirtazapine
Mirtazapine vs. placebo
|
|
Placebo Comparator: Arm 2
Placebo
|
Drug: Placebo
Mirtazapine vs. placebo
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00302107 History of Changes |
| Other Study ID Numbers: | MHBA-019-05F |
| Study First Received: | March 9, 2006 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Mirtazapine PTSD Veterans antidepressant |
Additional relevant MeSH terms:
|
Anxiety Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Mental Disorders Mirtazapine Mianserin Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Serotonin Antagonists Serotonin Agents Antidepressive Agents, Second-Generation |
ClinicalTrials.gov processed this record on May 19, 2013