NCT01587118已完成4 期
An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
Lori Davis, MD1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年6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
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total
研究概览
简要总结
This is an open-label pilot study of adjunctive asenapine for the treatment of Posttraumatic Stress Disorder (PTSD) in veterans who have not fully remitted to an adequate trial of standard antidepressant treatment.
详细描述
Consenting Veterans with the diagnosis of PTSD who have not fully remitted to an adequate trial of standard antidepressant treatment (sertraline, citalopram, escitalopram, fluoxetine, venlafaxine, or mirtazapine) are treated with the addition of open-label asenapine for 12-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Signed and dated informed consent and acceptable proof of identity.
- •Male or female subjects ≥19 to 65 years of age of any race or ethnic origin.
- •Not currently pregnant, breastfeeding or planning on becoming pregnant; use of contraception as follows:
- •Males - those that are sexually active must use a double barrier method of contraception (condom with spermicide) from the first dose of asenapine until 12 weeks after last dose of asenapine
- •Women of child-bearing potential - must have a negative urine pregnancy test and confirmed (by the investigator) use of a highly effective form of birth control for 3 months before enrollment and until 12 weeks after their last dose of asenapine.
- •Women of non-child bearing potential - women who are either permanently sterilized (hysterectomy, bilateral oophorectomy and bilateral salpingectomy but excluding bilateral tubal occlusion) or who are postmenopausal.
- •Diagnosis of PTSD (DSM-IV-TR criteria; confirmed by MINI and CAPS).
- •Total CAPS score >
- •Currently taking an approved antidepressant at acceptable dose for 8 weeks or more with non-remission of symptoms.
- •No substance use disorders of dependence (except for nicotine, caffeine) in previous 4 wks.
- •No substance use disorders of abuse (except for nicotine and caffeine) in the previous 2 wks.
- •Physical and laboratory panel (within past one year) are within normal limits or not clinically significant
排除标准
- •Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders (assessed by the MINI)
- •Actively considering plans of suicide or homicide (assessed by clinical interview)
- •Psychotic symptoms that in the investigator's opinion impair the subject's ability to give informed consent
- •A contraindication to the use of asenapine or antidepessant
- •Intolerable side effects or allergic reaction to asenapine or the current antidepressant
- •Women planning to become pregnant or breastfeed during the study
- •Clinically significant unstable or severe medical condition that would contraindicate study participation or expose them to an undue risk of a significant adverse event, including but not limited to: unstable or severe hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease; hypo- or hyperthyroidism, unless the condition has been stabilized; or a history of seizures (except for a single childhood febrile seizure, posttraumatic, or alcohol withdrawal). The following are exclusionary: platelets < 75,000/mm; hemoglobin <9g/dL; neutrophils, absolute < 1000/mm; LFTs > 3x upper limit; creatinine > 2 mg/dL; diastolic BP < 60 or > 110mmHg; EKG QTc > 475 msec.
- •In regard to vulnerable patient populations, persons with dementia, minors (<age 19), the elderly (>age 65), prisoners and the terminally ill are excluded.
研究组 & 干预措施
antidepressant plus asenapine
Experimental
adjunctive asenapine
干预措施: Adjunctive asenapine (Drug)
结局指标
主要结局
Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total
时间窗: baseline, week 4, 8, and 12
CAPS is the clinician rating of posttraumatic stress disorder (PTSD) symptoms; higher scores indicate higher severity of PTSD; 17-item score range 0 to 136. Blake DD, Weathers FW, Nagy LM, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress 1995; 8:75-90.
次要结局
- Change From Baseline in Brief Psychiatric Rating Scale (BPRS)(Baseline, week 4, 8, 12)
研究者
Lori Davis, MD
Associate Chief of Staff, Research and Development Service
Tuscaloosa Research & Education Advancement Corporation
研究点 (1)
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