NL-OMON34855尚未招募2 期
Efficacy of agomelatine 25 mg/day (with possible increase to 50 mg/day after 8 weeks of treatment) given orally during 16 weeks in patients with Obsessive-Compulsive Disorder.A randomised, double-blind, placebo-controlled, parallel groups, international study. - Efficacy of agomelatine in Obsessive-Compulsive Disorder
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Out patients, male or female, between 18 and 65 years inclusive with a primary diagnosis of Obsessive Compulsive Disorder (OCD) according to DSM-IV-TR. The diagnosis will be documented by the brief structured interview M.I.N.I.
- •- Patients previously treated for OCD with a first line pharmacological treatment, i.e, SRI with or without cognitive behavioural therapy .
- •- Y-BOCS total score * 20 (moderately to severely ill),
- •- Duration of OCD symptoms of at least one year,
- •- Requiring a treatment.
排除标准
- •cfr p. 25-26
- •- Episodic OCD, Exclusive hoarders, Early onset OCD
- •- Refractory patients defined as having not responded to 2 or more adequate treatments (medium or high) dose of a SRI for at least 12 weeks.
- •- Patients in psychiatric care for more than 5 years for OCD
- •- Naïve Patients (never received pharmacological treatment for OCD)
- •- Motor or verbal tic disorder (including Tourette*s),
- •- Substance or alcohol dependence or abuse
- •- personality disorders
- •- Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study (e.g., neurologic, neoplasic, cardiovascular, pulmonary, digestive or metabolic disorders like unstabilized diabetes of type I or II, morbid obesity, untreated or uncontrolled arterial hypertension*),
- •- Any clinically relevant abnormality detected during the physical examination, ECG or laboratory tests likely to interfere with the study conduct or evaluation,
- •- Hepatic impairment (i.e. cirrhosis or active liver disease),
- •- ASAT or ALAT values * 2 times the upper reference value
- •- Total bilirubin * 2 times the upper reference value or ALAT and total bilirubin >ULN
- •- Alkaline Phosphatase * 3 times the upper reference value,
- •- Women of childbearing potential without effective contraception (oral contraceptive pill, Intra-uterine contraceptive device or condom) as well as
- •- pregnant or breastfeeding women
- •- Concomitant psychotropic medications are forbidden during the study.
研究者
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