A Placebo-Controlled Study of Mirtazapine for PTSD

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Mianserin; Mirtazapine

Criteria

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