Phase III Open Study of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety as recorded by adverse-events and side-effects reports.
研究概览
简要总结
Objectives: To evaluate tolerability and efficacy of escitalopram treatment in high dose than 20-50 mg/d in out-patients with OCD Type of the study: Open label, prospective study.
Number of patients: 100 patients with OCD
Duration of the study: 18-weeks of active treatment, 8-visits:
Dose titration:
One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment- if partial/no response, according to YBOCS score and clinical judgment, dose increase of up to 50mg depending on response, adverse events, patient preference and judgment of the clinician 12 weeks follow up on high dose. Total of 18 weeks of follow-up.
详细描述
Objectives: To evaluate tolerability and efficacy of escitalopram treatment in doses higher than 20mg (20-50 mg/d) in patients with OCD, non responsive or partially responsive to recommended doses.
Type of the study: Open label, prospective study. Study location: Subjects will be recruited from patients treated in a large clinic specializing in mood disorders and anxiety and OCD.
Backup site: the ABARBANEL mental health center. Number of patients: 100 patients with OCD
Duration of the study: 18-weeks of active treatment, 8-visits:
Dose titration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years of age
- •DSM IV-TR criteria for OCD
- •OCD associated with most distress or most interference in the patient's life as judged by the treating physician
- •Yale-Brown Obsessive Compulsive Scale (YBOCS) total score ≥ 16
排除标准
- •Other primary or co-primary psychiatric disorder which is more distressful for the patient then the OCD, as evaluated by investigator
- •Patients with any history of mania/bipolar disorder
- •Patients using medications which are contraindicated with the use of escitalopram
- •Known contraindication for the use of citalopram or escitalopram.
- •Unable to understand and give informed consent
- •Prominent suicidal ideation (2 points or more in the MADRS "suicidal thoughts" item)
- •Alcohol or substance dependence in the past 6 months
- •Major physical illness
- •Woman currently pregnant or less then 4 weeks after a childbirth, a woman lactating, or a woman of childbearing potential not using a medically accepted form of contraception.
- •Liver function abnormality
- •EKG abnormalities
结局指标
主要结局
Safety as recorded by adverse-events and side-effects reports.
次要结局
- Reduction in YBOCS scores at week 18