Double-blind Trial of Acute and Intermediate-term Dextro-amphetamine Versus Caffeine Augmentation in Treatment Resistant Obsessive Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2
研究概览
简要总结
The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and that tolerance (loss of therapeutic effect) to the medication will not develop over a period of several weeks.
详细描述
The study will investigate whether dextro-amphetamine (d-amphetamine) is safe and effective compared to caffeine as an active placebo when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and whether tolerance (loss of therapeutic effect) to the medication will develop over a period of several weeks
D-amphetamine is approved by the U.S. Food and Drug Administration to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Because of the effects that d-amphetamine has on the brain, Dr. Koran believes it may be helpful in treating OCD. A positive finding in this study may stimulate research aimed at improving OCD treatment and understanding of the neurochemistry involved.
This research study will enroll 24 people who are taking medication for their OCD but are not receiving sufficient benefit. The research will be performed only at Stanford University.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatient age 18 through 55 inclusive
- •meets DSM-IV criteria for obsessive-compulsive disorder (OCD) with Yale-Brown Obsessive-Compulsive Scale (YBOCS) score greater than or equal to 20
- •provides written informed consent
- •has taken for at least 12 weeks at least the dose shown of a selective serotonin reuptake inhibitor (SSRI) [citalopram, escitalopram, or fluoxetine 20 mg/d; paroxetine 40 mg/d; sertraline 50 mg/d]; or venlafaxine 225 mg/d; or duloxetine 60 mg/d.
- •if taking buspar, gabapentin, an atypical antipsychotic, or a benzodiazepine, dose has been stable for 4 weeks
- •has negative urine drug and pregnancy tests
- •is practicing reliable birth control method
- •has blood pressure readings at screening visit that are less than 140 mm Hg systolic and 90 mm Hg diastolic,
- •weight is greater than 100 lbs at screen
- •Exclusion criteria:
- •requires psychotropic medications other than an Serotonin Reuptake Inhibitor (SRI), a benzodiazepine, buspirone, an atypical antipsychotic, and/or gabapentin
- •is taking clomipramine
- •is taking fluvoxamine
- •is taking medication that inhibits hepatic enzyme CYP1A2
- •is taking a monoamine oxidase inhibitor
- •has co-morbid tics or Tourette's disorder
- •has hoarding as the primary or only OCD symptom
- •has a history of panic disorder
- •has a history of glaucoma
- •has a history of seizures
- •has a history of schizophrenia or psychotic disorder, or schizotypal personality disorder
- •has depression with current suicide risk
- •has mental retardation, pervasive developmental disorder, or cognitive disorder
- •has a factitious disorder
- •has current or past cyclothymic disorder or bipolar disorder
- •has a dissociative disorder
- •has personality disorder sufficient to interfere with study participation
- •has organic mental disorder or dementia
- •has current or past substance abuse / dependence (excluding nicotine)
- •has current or past anorexia or bulimia
- •has serious or unstable medical disorder, including hypertension or cardiac disease
- •has history of myocardial infarction or cardiac arrhythmia
- •has history of or has current diagnosis of hypertension
- •is pregnant or breast-feeding
- •is receiving psychotherapy for OCD
- •is intending to receive psychotherapy for OCD during the study
- •has had a previous trial of d-amphetamine of at least 30 days duration
- •is unable to speak, read, or understand English
- •is not likely to follow study procedures
- •is not suitable for study in the investigator's opinion
排除标准
- 未提供
研究组 & 干预措施
d-amphetamine
dextro-amphetamine capsules, 15 mg per capsule, in Bottles A and B, dose: one from Bottle A each morning and 1 from Bottle B each morning
干预措施: dextro-amphetamine (Drug)
Sham comparison
caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules, dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning
干预措施: Sham Comparison (Drug)
结局指标
主要结局
Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2
时间窗: At end of week 5, except 1 d-amphetamine subject rated at end of week 2
Clinical Global Impressions Scale Improvement Score = 1 (very much improved), or 2 (much improved). Additional possible scale scores are 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse).
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
时间窗: At end of week 5, except 1 d-amphetamine subject rated at end of week 2
Yale-Brown Obsessive-Compulsive Scale score by blinded investigator in direct interview. The scale score is the sum of ten items (5 for obsessions and 5 for compulsions: time occupied, degree of interference with functioning, degree of distress, effort to resist the symptom, success in resisting), each rated from 0 to 4, with higher scores indicating more severe OCD. Maximum score is 40. Scores of 14 and below are often described as "subclinical," though patients with these scores may still exhibit troubling symptoms and mild to moderate distress. A total score of 8 or less is often termed "remission." A decrease in total score from baseline to endpoint of either 25% or 35% is often used as a "responder" criterion in clinical trials.
次要结局
未报告次要终点
研究者
Lorrin M Koran
Professor of Psychiatry, Emeritus
Stanford University