A Placebo-Controlled Study of Mirtazapine for PTSD

Completed · Phase 4 · Has a placebo group

Conditions studied: Anxiety, PTSD

In brief

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.

Key facts

Study ID

NCT00302107

Run by

US Department of Veterans Affairs

People needed

78

Starts

2006-04-01

Expected to finish

2012-06-01

Last updated by the study team

2014-11-26

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tuscaloosa VAMC — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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