Treatment for Psychogenic Nonepileptic Seizures: A Pilot, 12 Week, Prospective, Randomized, Placebo-controlled, Double-blind, Clinical Trial of Sertraline in the Treatment of Comorbid Psychiatric Disorders in NES
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of Nonepileptic Seizures (NES)
研究概览
简要总结
The investigators propose that treatment of the comorbid disorders (depression, anxiety, and impulsivity) with sertraline in patients with lone psychogenic nonepileptic seizures (NES), will result in a decreased number of NES. The purpose of this study is to provide pilot testing and data to inform the future randomized controlled trial based on the hypothesis.
详细描述
This is a pilot, prospective, single center, randomized, placebo-controlled, double-blind trial, that assesses the number of NES in patients treated with flexible dose sertraline (Zoloft). This study will provide outcomes data and the effect size necessary for a future R01, multi-center randomized control trial. Secondary objective variables include reduction in depression, anxiety, impulsivity scores, and improvement in psychosocial functioning.
After being diagnosed with NES by video electroencephalogram monitoring (vEEG), up to 50 participants will be enrolled and monitored during a two week lead in period for their baseline NES and psychosocial symptoms and functioning. At week 2, they will be blindly randomized to the treatment arm with flexible dose sertraline (25 to 200mg) or to the placebo control arm. The dose will be titrated over 4 weeks up to 200mg or to dose limited by side effects. The subjects will stay on their maximum fixed dose for the next 4 weeks. At week 10, the subjects may elect to remain on the sertraline or they can taper off the medication over the final two weeks of the treatment trial.
After the treatment trial, the subjects will have follow up phone calls at month 4, 8, and 12 after enrollment to assess seizure status, medication usage, and global functioning.
Upon enrollment, subjects will be evaluated with a structured psychiatric and neurological exam, and with bi-weekly, 30 to 60 minute appointments where they will complete symptom and function scales. They will keep a seizure diary prospectively, to evaluate their daily seizure activity. They will be given two weeks of the medication at each visit.
In the first phase of the study 12 patients were screened and 8 enrolled in an open label trial of flexible dose sertraline. In the second phase of the study, 38 patients enrolled in the pilot, randomized, placebo-controlled trial.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Video electroencephalogram (vEEG) confirmed diagnosis of NES
- •Have at least one nonepileptic seizure per month
- •Comorbid diagnosis of either depression, anxiety, or post traumatic stress disorder (PTSD)
- •Able to complete self report symptom scales
- •Not receiving optimized antidepressant medication
排除标准
- •Equivocal electroencephalogram (EEG) findings
- •Current suicidality, litigation, or self-mutilation
- •Using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan
- •Allergy/sensitivity to sertraline
- •Current alcohol/drug dependence
- •Serious medical illness requiring current hospitalization
研究组 & 干预措施
sertraline
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
干预措施: sertraline (Drug)
placebo
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
干预措施: placebo (Drug)
结局指标
主要结局
Number of Nonepileptic Seizures (NES)
时间窗: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.
次要结局
- Oxford Handicap Scale (OHS)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Global Assessment of Functioning (GAF)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Davidson Trauma Scale (DTS)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Symptom Checklist 90 (SCL-90)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Beck Depression Inventory-II (BDI-II)(bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12)
- Modified Hamilton Depression Scale (MHRS)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Barratt Impulsivity Scale (BIS)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Dissociative Experiences Scale (DES)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Clinical Global Impressions - Improvement (CGI-I)(Weeks 2, 6, 10)
- Family Assessment Device (FAD)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Clinical Global Impressions - Severity (CGI-S)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
- Quality of Life in Epilepsy-31 (QOLIE-31)(Baseline and weeks 2, 6, 10 (total time frame of 12 weeks))
研究者
W. Curt LaFrance Jr., M.D.
PI
Rhode Island Hospital