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临床试验/NCT01404871
NCT01404871已完成不适用

Predicting Medication Response in Obsessive Compulsive Disorder

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
YBOCS Obsessive-Compulsive Severity Score

研究概览

简要总结

In this study, the investigators hope to study a number of variables the investigators believe may help us predict why some people respond better to some medications than others. Participants will be randomly assigned to receive one of two typical medications for OCD, clomipramine or escitalopram. Individuals who would like to participate but who have previously tried one or both of these medications may instead take a newer drug, duloxetine, and undergo the identical procedures. The factors the investigators will be studying include demographics (i.e. age, gender, age of onset of OCD), genetic markers (such as variants in genes involved in breaking down drugs in the liver (cytochrome P450 system), and genes involved in several brain chemical systems, such as serotonin), the dimensions of OCD symptoms (i.e. checking, washing, and hoarding) and cortical inhibition. Cortical inhibition will be measured transcranial magnetic stimulation and is being studied because deficits in this process may be important in the development of OCD. The investigators hypothesize that certain pretreatment clinical characteristics will correlate with poor treatment response including earlier age of onset, longer duration of illness, increased YBOCS severity and presence of significant hoarding symptoms. The investigators expect that increasing degree of deficit in CI pre-treatment will predict poor treatment response, but that increase in CI from pre- to post-treatment will correlate with a positive treatment response. Differences in genetic marker status for cytochrome P450 genes will correlate with tolerability and/or response, as well as differences in genetic marker status in SLC1A1, GRIN2B, 5HT1B and 5HT2A will correlate with response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (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

入选标准

  • Clinical diagnosis of Obsessive Compulsive Disorder
  • Must be able to swallow tablets

排除标准

  • History of stroke
  • History of Parkinson's disease
  • History of Epilepsy
  • Clinical diagnosis of Schizophrenia or schizoaffective disorder
  • Clinical diagnosis of Bipolar Affective disorder
  • Active suicidality

研究组 & 干预措施

Randomization to ECIT or CMI

Active Comparator

Randomized trial of clomipramine or escitalopram

干预措施: escitalopram (Drug)

Randomization to ECIT or CMI

Active Comparator

Randomized trial of clomipramine or escitalopram

干预措施: clomipramine (Drug)

Open label Duloxetine

Active Comparator

Open label trial of duloxetine

干预措施: duloxetine (Drug)

结局指标

主要结局

YBOCS Obsessive-Compulsive Severity Score

时间窗: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)

The YBOCS yields an OCD severity score by scoring participants on time, interference, distress, resistance and control of their obsessive and compulsive symptoms on a scale of 0-4. When these scores are summed, they give a total severity score from 0-40. The primary outcome will measure the degree of change in this measurement from pre- to post-treatment.

Clinical Global Improvement - Improvement Scale

时间窗: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)

This is a clinician/Research assistant rated score of clinical improvement. Both treating physician and research assistant (who interviews the participant every two weeks) will independently provide ratings from 1-7, 1 being very much improved and 7 being very much worse.

次要结局

  • Change in cortical Inhibition (CI) as measured with Transcranial Magnetic Stimulation.(Pre- and post-treatment (typically, 0 weeks and 12 weeks))
  • Genotype marker data for SLC1A1, GRIN2B, 5HT1B, 5HT2A and P450 enzymes CYP2D6 and CYP2C19.(Collected at week 0, analyzed periodically (approx. 1x/year))
  • Tolerability/side effects measure with Udvalg for Liniske Undersogelser Side Effect Rating Scale (UKU).(Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks))
  • Clinical Global Impression - Severity Scale.(Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks))
  • Depression symptoms will be rated with the Beck Depression Inventory (BDI).(Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks))
  • DYBOCS (Dimensional Yale-Brown Obsessive-Compulsive Scale)(start, middle and end of trial (typically, 0, 6 and 12 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Peggy Richter

Director, Clinic for OCD & Related Disorders Head, Frederick W. Thompson Anxiety Disorders Centre Dept. of Psychiatry, Sunnybrook Health Sciences Centre Associate Professor of Psychiatry, University of Toronto

Sunnybrook Health Sciences Centre

研究点 (2)

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