A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Structured Interview of Posttraumatic Stress Disorder (SIP)
研究概览
简要总结
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.
详细描述
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
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1
Mirtazapine
干预措施: Mirtazapine (Drug)
Arm 2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Structured Interview of Posttraumatic Stress Disorder (SIP)
时间窗: Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score.
Structured Interview of Posttraumatic Stress Disorder (SIP) is a 17-item clinician-administered scale for PTSD based on Diagnostic Statistical Manual-IV criteria. The SIP has excellent test-retest reliability (0.89; p=.00001), and internal consistency (Conbach α of 0.80). The SIP showed significant correlations with the DTS (r=0.67, p=.0001) and the Impact of Event Scale (r=0.49 p=.0001). Relative to the SCID diagnosis of PTSD, sensitivity, specificity, positive predictive value, negative predictive value, and efficiency values were 100% for all indices using a score of 20 on the SIP. Items are scored on a scale from 0-4 which are summed to yield a total score ranging from 0 to 68 (higher score means more symptomatic or worse outcome). A symptom is counted as positive if it is at least a 2 (moderate).
次要结局
未报告次要终点