A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans
Information source: Tuscaloosa Research & Education Advancement Corporation
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: PTSD
Intervention: Mirtazapine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Tuscaloosa Research & Education Advancement Corporation Official(s) and/or principal investigator(s):
Lori L. Davis, MD, Principal Investigator, Affiliation: Tuscaloosa VA Medical Center
Overall contact:
Lori L Davis, MD, Phone: (205) 554-3819, Email: Lori.Davis@va.gov
Summary
The primary objective is to evaluate the efficacy and tolerability of mirtazapine (Remeron)
in the treatment of PTSD. Primary Hypothesis to be tested: Veterans with PTSD will have
improvement in their symptomatology after 8 weeks of treatment with mirtazapine compared to
those treated with placebo. After completion of the placebo-controlled phase, patients who
agree to continue in the study will be treated with open-label mirtazapine for an additional
8 weeks.
Clinical Details
Official title: A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: CAPS score improvement
Secondary outcome: Side effect assessments
Detailed description:
After meeting inclusion criteria, the patients enter an 8-week randomized, double-blind,
placebo-controlled treatment trial of mirtazapine. After completion of the placebo-controlled
phase, patients may continue study participation in an open-label mirtazapine for an
additional 8 weeks.
The VA Pharmacy has an established working relationship with the investigators. The
pharmacist maintains the randomization log and verifies the order for the placebo or
mirtazapine (15mg) in look-a-like capsules. The investigators and patients are kept blind to
the contents of the capsules until the end of the entire study. See procedure grid in
attached Work Proposed Section attached. Based on symptomology and occurrence of side
effects, the investigator increases the medication in 15 mg (one capsule) increments every
week, as tolerated, until a maximum therapeutic benefit is achieved, not to exceed 45 mg/day
(3 capsules). The dosing is at bedtime. Compliance is assessed by biweekly pill count.
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. At the end of the placebo-controlled phase, if the patients agree to continue in
the study (confirmed at every visit) and they have not experienced an intolerable side effect
related to the study medication, the patient will stop the placebo-controlled medication and
begin open label mirtazapine, starting with 15mg at bedtime and titrating as tolerated to a
maximum of 60mg/day.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of PTSD, confirmed by 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 ethic 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
Locations and Contacts
Lori L Davis, MD, Phone: (205) 554-3819, Email: Lori.Davis@va.gov
Tuscaloosa VA Medical Center, Tuscaloosa, Alabama 35404, United States; Recruiting
Lori L Davis, MD, Principal Investigator
Additional Information
Related publications: Kim W, Pae CU, Chae JH, Jun TY, Bahk WM. The effectiveness of mirtazapine in the treatment of post-traumatic stress disorder: a 24-week continuation therapy. Psychiatry Clin Neurosci. 2005 Dec;59(6):743-7.
Starting date: October 2006
Ending date: December 2010
Last updated: June 23, 2008
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