A Placebo-Controlled Study of Mirtazapine for PTSD
Condition: Anxiety; PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Mirtazapine; Placebo
Intervention description: Mirtazapine initiated at 15mg qhs and titrated in 15mg increments to a maximum of 45 mg qhs as tolerated.; Look-a-like placebo tablets under double-blind conditions
Intervention MeSH terms: Mirtazapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mirtazapine; PTSD; Veterans; antidepressant

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.
    

Eligibility 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