Overview

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