NCT02384369撤回2 期
Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Efficacy, Safety, and Pharmacokinetics of Orally Administered SNC-102 in Subjects With Combat-Related Posttraumatic Stress Disorder Concomitantly Treated With Prazosin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- PTSD symptoms as measured by Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual-5 (CAPS-5)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects with cPTSD, added to pre-existing treatment that includes prazosin with or without other psychotropic drugs.
Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8 weeks. Subjects will be evaluated for the symptoms of combat-related posttraumatic stress disorder (cPTSD) as measured by the Clinician Administered PTSD Scale (CAPS-5), compared with the response to placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of a diagnosis by a Board-Certified psychiatrist of combat-related posttraumatic stress disorder (cPTSD) according to Diagnostic and Statistical Manual (DSM-5) criteria for PTSD and a history linking the symptoms to combat exposure.
- •Taking prazosin for treatment of cPTSD for a minimum of 4 weeks, on a stable dose for at least 2 weeks, and expected to remain on that dose for the duration of the study.
- •Having sufficient residual symptoms of PTSD while on the current drug regimen that, in the opinion of the Principal Investigator, additional treatment of the disorder is clinically indicated.
- •Body mass index of 18-38 kg/m2 inclusive.
排除标准
- •Plans to initiate a new psychotropic medication (other than the study drug) during the period of the study.
- •Plans to change the dose or discontinue prazosin or a psychotropic medication during the period of the study.
- •Diagnosis of epilepsy or treatment with an antiepileptic drug.
- •Use of alcohol or cannabis to the extent that, in the view of the Principal Investigator, it raises a significant risk of medication noncompliance, drinking alcohol after midnight on the days of study visits or missed study visits. Any use of non-prescribed opiates, cocaine, or other street drugs other than cannabis in the month prior to study entry.
- •Any history of major medical complications of alcohol use including alcoholic hepatitis, cirrhosis of the liver, pancreatitis, alcohol withdrawal seizures, or delirium tremens.
- •Patients taking moderate, stable doses of oral opiates for chronic pain may be admitted at the discretion of the Principal Investigator.
- •Current use of a drug other than prazosin with significant alpha-adrenergic blocking effects, if associated with symptomatic orthostatic hypotension.
- •Current use of cocaine, amphetamine, phencyclidine, or ketamine, documented either by history or by urinary drug screening at Screening and Baseline Visits. Urinary drug screening for ketamine and phencyclidine will conducted off-site by the Study Sponsor if urinary drug screening available at the study site does not include these drugs. Any other drugs identified incidentally on drug screening will warrant exclusion only if the Principal Investigator, in consultation with the Sponsor, judges that their presence could interfere with the objectives of the trial.
- •Pregnant or lactating female.
- •Women of childbearing potential, unless the subject agrees to use dual contraceptive methods while on study drug and for 1 month afterward, which, in the opinion of the Principal Investigator, are effective and adequate for that subject's circumstances.
- •Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that could increase the risk associated with study participation or study drug administration, could interfere with the informed consent process and/or with compliance with the requirements of the study, or could interfere with the interpretation of study results and which, in the Principal Investigator's opinion, would make the subject inappropriate for entry into this study.
- •Use of any non-pharmacologic psychiatric somatic treatment within 4 weeks of baseline, or expected during the course of the study. Such treatments include but are not limited to electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, light therapy, and acupuncture.
研究组 & 干预措施
SNC-102 sustained release tablet
Experimental
SNC-102 sustained release tablet for oral administration, 1600 mg BID for 8 weeks
干预措施: SNC-102 sustained release tablet (Drug)
Placebo
Placebo Comparator
Placebo tablet for oral administration, BID for 8 weeks
干预措施: SNC-102 sustained release tablet (Drug)
结局指标
主要结局
PTSD symptoms as measured by Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual-5 (CAPS-5)
时间窗: 8 weeks
Determine whether SNC-102 at a dose of 1600 mg twice daily (BID), added to pre-existing treatment that includes prazosin, will decrease the symptoms of combat-related posttraumatic stress disorder (cPTSD) as measured by the CAPS-5, compared with the response to placebo.
次要结局
未报告次要终点
研究者
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