Study of Mirtazapine for Post-Traumatic Stress Disorder (PTSD) in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans and Veterans From All Other Southwest Conditions
| Status: | Archived |
|---|---|
| Conditions: | Anxiety, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans
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.
Title: A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans and Veterans
from all other Southwest Asia Conditions
Sponsor of the study: VA Merit grant pending
Research Setting: Subjects will be recruited from the mental health and primary care
outpatient clinics and inpatient units. The informed consent process will be conducted in a
private setting. Rating scales and laboratory procedures will also be performed in a private
setting.
Purpose of the study including hypothesis to be tested: 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.
Background, including results of relevant research, gaps in the current knowledge PTSD is a
common mental illness, afflicting about 3 percent of persons, or 12 million North Americans.
PTSD is a common consequence of disasters, rape, auto accidents, and violent crime, with
about half of trauma victims suffering acute symptoms. One fourth of victims of acute PTSD
progress to develop chronic PTSD.
Presently, there are only two medications indicated for PTSD (sertraline and paroxetine).
Long-term effects of untreated PTSD are serious, including depression, alcohol and drug
abuse, violence, and suicide.
The VA Healthcare System is a natural clinical laboratory for study of PTSD, since 14 - 30 %
of Vietnam Combat Veterans continue to suffer consequences of this disorder.
Preliminary clinical data from an open studies and one small placebo-controlled study of
mirtazapine in the treatment of PTSD suggests that mirtazapine is effective and may have a
unique pharmacological profile in treating PTSD.
Potential Benefits to the research subject and knowledge to be gained: The actual patient
participant may benefit from further reduction in underlying psychiatric symptoms. There is
substantial potential for knowledge about PTSD treatment to be gained by the cumulative data
gathered in this study that may improve the health care of veterans and nonveterans in the
future.
Definition of the population to be studied and justification: The population to be studied
is outpatient veterans with current PTSD, diagnosed by the use of the MINI. Patients may be
recruited from mental health, inpatient units or Primary Care Outpatient Clinics, however;
the majority of the study is intended to be outpatient. The justification for use of a PTSD
population is that new treatments for PTSD are needed, particularly with combination of
medications since monotherapy rarely is fully effective.
Number of subjects: 100 subjects enrolled. Subjects must meet each of the following
inclusion and exclusion criteria in order to be randomized.
Subject 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 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
Exit Criteria (One needed to exit):
Completion of the study Severe and intolerable side effects to mirtazapine/placebo treatment
Acute development of suicidal ideation, homicidal ideation or psychotic symptoms Symptoms
worsen (Score of 7 (very much worse) on CGI-I. Participant's explicit request to exit the
study The need for additional psychotropic drugs, other than the study drug or adjunctive
medication as specified in the protocol, for the control of the subjects psychiatric
symptoms.
The subject becomes pregnant during the course of the study. Investigator's judgment that it
is no longer in the best interest of the patient to continue in the study.
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