View Clinical Trial (Medical Research Study)
A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans and Veterans From All Other Southwest Asia Conditions
| City: |
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Tuscaloosa |
| State: |
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Alabama |
| Zip Code: |
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35404 |
| Conditions: |
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PTSD |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00449189 |
| Primary Contact: |
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Principal Investigator
Lori L. Davis, MD
Tuscaloosa VA Medical Center
Lori L Davis, MD
Phone: (205) 554-3819
Email: Lori.Davis@va.gov
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| Backup Contact: |
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Email: Beverly.Whitfield@va.gov
Beverly Whitfield, MA
Phone: (205) 554-2000 ext. 2733
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| Location Contact: |
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Tuscaloosa, Alabama 35404
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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