NCT01715519已完成4 期
A Double-blind, Placebo-controlled Randomized Trial of Vilazodone in the Treatment of Posttraumatic Stress Disorder
Southern California Institute for Research and Education2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- PTSD Diagnosis
研究概览
简要总结
The purpose of this study is to determine whether vilazodone is effective in the treatmen of Posttraumatic Stress Disorder (PTSD)and co-morbid mild or more depression.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must satisfy DSM-IV diagnostic criteria for chronic PTSD
- •Evidence of PTSD disease base upon one or more of the following:
- •Mild or greater depression on the Beck Depression Inventory -II (BDI-II, score> 12).
- •May have other symptom co-morbid with PTSD (e.g., anxiety or somatic pain)
- •Ability to comprehend and satisfactorily comply with protocol required and signed written informed consent prior to entering study procedure
- •May be in psychotherapy if initiated at least three months prior to the screening visit. Subject must not discontinue or otherwise alter therapy during the study.
- •Subject may not have taken any psychopharmacological medications within 7 days prior to Baseline visit.
- •Negative urine pregnancy test at screening visit and for the duration of the study for women of childbearing potential.
排除标准
- •Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:
- •Delirium, Dementia, Amnestic and other Cognitive disorders
- •Lifetime Schizophrenia and other Psychotic Disorders
- •lifetime Bipolar I Disorder
- •Bipolar-II Disorder with an episode of hypomania within the last year
- •Alcohol or Substance Dependence or Abuse (excluding nicotine) in one month prior to the Screening Visit
- •Any other concurrent Axis I Disorder (including Major Depressive Disorder) must be secondary to the primary diagnosis of PTSD.
- •Decisional incapacity (dementia)
- •Use of centrally acting medications that potentially have an effect on biological expression
- •Chronic pain levels requiring use of any opiate medications
- •Known exposure to chemicals of physical traumas that cause neuropsychiatric sequelae
- •Past chronic PTSD
- •History of 2 or more treatment failures on SSRIs given primarily for the treatment of PTSD, in adequate does at the Investigator's opinion, for at least 8 weeks
- •History of intolerance or hypersensitivity to SSRI's
- •History of seizures
- •Significant risk of committing suicide, or are homicidal or violent and in the Investigator's opinion in significant imminent risk of hurting others
- •Treated with depot-neuroleptic within 3 months or MAO inhibitors within 30 day prior to Baseline visit
- •Received ECT within 3 months prior to Screening visit
- •Pregnant or nursing, women of childbearing potential who are sexually active and do not use adequate contraception, or who are judged to be unreliable in their use of contraception
- •Positive urine drug screen, unless proven to be prescribed for a short-term course of treatment. Drug screen must be repeated at least 7 days after the last dose of prescription medication containing narcotics
- •A medical condition, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial
- •Requiring concomitant treatment with any psychotropic drug (except zolpidem for sleep)
- •Plans to initiate or terminate any form of psychotherapy or behavior therapy during the study
- •Receiving disability payments (> 50 % service connections or total Social Security) or who are involved in litigation for PTSD or other psychiatric illnesses.
- •Unable to speak, read, and understand English or are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits
研究组 & 干预措施
Treatment (Viibryd)
Experimental
10 mg/day 1 to 7; 20 mg/day 8 to 14; 40 mg/day week 3 to end week 12. Subjects will then be tapered off vilazodone as follows: 20 mg/day week 13, 10 mg/day, week 14 and no medication during week 15.
干预措施: Treatment (Viibryd) (Drug)
Placebo
Placebo Comparator
will be compared to the treatment group (viibryd)
干预措施: Treatment (Viibryd) (Drug)
结局指标
主要结局
PTSD Diagnosis
时间窗: 4 months
CAPS
PTSD symptoms
时间窗: four months
PCL-C
次要结局
- Depression(four months)
- Sleep(4 months)
- Anxiety(4 months)
研究者
Michael Hollifield, MD
Director of Program for Traumatic Stress
Southern California Institute for Research and Education
研究点 (2)
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