Curcumin as add-on to Antipsychotic Treatment in Chronic Schizophrenia Patients: A Randomized, Double-Blind, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Positive and Negative Symptoms Scale (PANSS)
研究概览
简要总结
Schizophrenia is still remained one of the disabling disorders despite progress in treatment of mental disturbances. Ten to thirty percents of patients have a little or no benefit from treatment with all kinds of antipsychotics using adequate dosages and duration. Treatment of these patients has remained a persistent public health problem since medication-resistant patients are often highly symptomatic. Curcumin is one of the main curcuminoids isolated from this perennial herb. It possesses a variety of pharmacological activities, including anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects and crosses the blood-brain barrier. The purpose of our suggested study is to examine the efficacy of curcumin as add-on the conventional antipsychotic psychopharmacotherapy in chronic schizophrenia patients.
详细描述
Study Design This is a 24-week, randomized, double-blind, placebo-controlled investigation of 40 chronic schizophrenia patients.
Participants Forty patients will be drawn from the patient population of Be'er Sheva Mental Health Center. Recruitment period will last over 2 years.
Patients will be required to have a primary diagnosis of chronic schizophrenia as defined in DSM-IV with predominantly persistent negative signs.
The study will commence only after approval by the local Institutional Ethics Review Board ("Helsinki Committee"). Only willing subjects and able to provide written informed consent, after receiving a comprehensive explanation of the study procedures, will be included in the study. Confidentially will be ensured by means of a number coding system, and all completed research forms will be stored in secure areas.
Procedure Patients will continue receiving their regular antipsychotic medication. The dose will be kept constant for at least 3 months prior to entry and throughout the study period. Curcumin is provided as Curcumin Forte ® (Solgar Israel SupHerb). Circumin capsules are supplied as an 1000 mg soft gelatin capsule for three daily oral administration with meals. At entry patients will receive curcuma capsules (3000 mg/day, three capsules) or placebo in identical capsules in a randomized, double blind mode for 24 weeks: 20 patients will receive curcumin, and 20 patients - placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years, male or female
- •DSM-IV criteria for schizophrenia.
- •Ability and willingness to sign informed consent for participation in the study
- •SANS (Scale of Negative Symptoms of Schizophrenia ) > 30 points
- •Fixed antipsychotic dosages at least 3 months
- •Steady mental state of patients at least 3 months
排除标准
- •Current substance use disorder except nicotine dependence
- •Regular use of NSAID (non-steroidal anti-inflammatory drugs)
- •Cancer history
- •Untreated or severe hypertension
- •Poorly controlled diabetes mellitus Type I or Type II
- •Chronic liver & gallbladder diseases
- •Recent GERD (Gastroesophageal Reflux Disorder)
- •Neurological disorders: epilepsy, stroke
- •Hamilton Depression Scale Hamilton Depression Rating Scale (HAM-D-17 item) > 24 points
- •Patients with a known hypersensitivity to curcumin
- •Pregnant women or a woman who intends to become pregnant
研究组 & 干预措施
curcumin
curcumin 3 g/day for 6 months
干预措施: Curcumin (Drug)
curcumin
curcumin 3 g/day for 6 months
干预措施: placebo (Drug)
placebo
curcumin 3 g/day for 6 months
干预措施: Curcumin (Drug)
placebo
curcumin 3 g/day for 6 months
干预措施: placebo (Drug)
结局指标
主要结局
Positive and Negative Symptoms Scale (PANSS)
时间窗: up to 24 weeks
baseline and every week 4 up to 24 weeks
次要结局
- Clinical Global Impression - Improvement (CGI-I)(up to 24 weeks)
- Clinical Global Impression - Severity of Adverse Events (CGI-SAE)(up to 24 weeks)
- Calgary Depression Scale for Schizophrenia (CDSS)(up to 24 weeks)
研究者
Vladimir Lerner
Associate Professor
Beersheva Mental Health Center