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临床试验/NCT00854919
NCT00854919已完成4 期

An Long Term Trial on Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder

Osaka City University1 个研究点 分布在 1 个国家开始时间: 2006年1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
试验地点
1
主要终点
Yale-Brown Obsessive-Compulsive Scale

研究概览

简要总结

Objective: Although atypical antipsychotic drugs (AAPDs) have been found effective in the augmentation of serotonin reuptake inhibitors (SRIs) for treatment-resistant obsessive-compulsive disorder (OCD) in short terms trials, there are few data on the effectiveness and safety of these agents in clinical settings over the long term.

Method: Subjects (n=46) who responded to selective SRIs (SSRIs) in an initial 12-week trial were continued on SRI-monotherapy plus cognitive-behavioral therapy (CBT) for one year. Subjects (n=44) who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such as risperidone and were consecutively treated using SSRI+AAPD combined with CBT for a year.

详细描述

More recently, second-generation atypical antipsychotic drugs (AAPD) that modulate both 5-HT and DA function, such as risperidone (RIS), olanzapine (OLZ) and quetiapine (QET), have been found effective in the augmentation of SSRIs for treatment-resistant OCD.

Nevertheless, the AAPDs have been associated with common and serious adverse effects, such as body weight (BW) gain and metabolic dysregulation. Metabolic dysregulation includes glucoregulatory dysfunction and dyslipidemia. Indeed, studies of some AAPD in SSRI-refractory OCD patients have similarly reported significant BW gain. AAPD-induced BW gain may influence patients' adherence to medication and places them at risk for a broad range of medical problems.

Most work on AAPDs in treatment-refractory OCD has been conducted in the form of short-term efficacy studies. There have been fewer studies of the effectiveness, safety, and tolerability of these agents in the context of a clinic where CBT is also provided, and where treatment is continued for a significant period of time. In the current effectiveness study, we sought to examine the response of SSRI-refractory patients to augmentation with AAPDs, comparing adverse events in such compared to a control group of SSRI responders.

研究设计

研究类型
Interventional

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, 18 years of age or over
  • Patients were diagnosed as having obsessive-compulsive disorder by the Structured Clinical Interview for DSM-IV Patient version (SCID-P)
  • They received standardized treatment for at least 1 year at the OCD clinic in our university hospital.
  • Each subject gave written informed consent to take part after receiving a complete description of this study.
  • All subjects were free of medical illness based on results of physical examination and screening tests of blood and urine, and no subjects received any lipid lowering or hypoglycemic agent during the 1-year study period.

排除标准

  • Current clinically significant medical conditions such as diabetes

研究组 & 干预措施

CBT

Experimental

All subjects received cognitive-behavioral therapy (CBT) during the study period.

干预措施: exposure response prevention (Behavioral)

1

Experimental

Drug; Paroxetine (30-50mg/D)or Fluvoxamine (150-250mg/D), 1-year administration

干预措施: atypical antipsychotic drug (Drug)

1

Experimental

Drug; Paroxetine (30-50mg/D)or Fluvoxamine (150-250mg/D), 1-year administration

干预措施: exposure response prevention (Behavioral)

2

Active Comparator

Either risperidone (1-5mg/D), olanzapine (1-5mg/D) or quetiapine (25-100mg/D) was added to ongoing SSRI, the combination trial was continued at least for half a year.

干预措施: atypical antipsychotic drug (Drug)

2

Active Comparator

Either risperidone (1-5mg/D), olanzapine (1-5mg/D) or quetiapine (25-100mg/D) was added to ongoing SSRI, the combination trial was continued at least for half a year.

干预措施: exposure response prevention (Behavioral)

结局指标

主要结局

Yale-Brown Obsessive-Compulsive Scale

时间窗: 1 year

次要结局

  • yale-Brown Obsessive-Compulsive Scale(1 year)
  • BMI, TG, T-CHO, FBS(1 year)

研究者

申办方类型
Other

研究点 (1)

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