IRCT2017012832236N1已完成3 期
Study of the efficacy and safety of Nigella sativa (black seed) as an adjuvant to antipsychotics in patients with chronic schizophrenia: A 6-week, randomized, double-blind, placebo-controlled trial
Vice chancellor for research, Mazandaran University of Medical Sciences0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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 years 至 65 years（—）
- 性别
- All
入选标准
- •1- Male or female inpatients in two long-stay Psychiatric Care and Rehabilitation Centers which are Supervised by Iranian Rehabilitation Institute located in Sari in the north of Iran
- •2-18–65 years at the time of screening
- •3-With a diagnosis of schizophrenia(paranoid, disorganized, catatonic, or undifferentiated type)or schizoaffective disorder, based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Five Edition(DSM-V)and they are suffering from the disease for more than 2 years with residual symptomatology despite antipsychotic treatment
- •4- All patients are on antipsychotics for at least 1 year and a stable dose for at least 2 month are included in the trial and the antipsychotics dose remain unchanged during the trial.
- •5-Mood stabilizers (lithium and divalproex) and antidepressants (only the selective serotonine reuptake inhibitors (SSRIs) venlafaxine, and mirtazapine) were permitted as part of antipsychotic pharmacotherapy. Dose of these drugs must be stable for at least 2 month remain unchanged during the trial.
- •Exclusions criteria:
- •1-Acute relapse (As acute relapse was defined an impending decompensation based on a PANSS score of =4 (moderately) on the subscore items of hostility and uncooperativeness and/or a =20% increase in the PANSS total score.
- •2-Psychiatric comorbidity(primary or secondary diagnosis of bipolar I disorder, either manic or mixed episode, as defined by Diagnostic and Statistical Manual of Mental Disorders, Five Edition(DSM-V))
- •3-History of substance dependence (including alcohol, but excluding nicotine) as defined by Diagnostic and Statistical Manual of Mental Disorders, Five Edition(DSM-V)and relapse within the past 6 months, or substance abuse within the 3 months preceding the trial or positive urine test for illicit drugs
- •4-Electroconvulsive therapy during the 6 past months
- •5-Suicidality(active suicide or homicide intent, or a suicide or homicide attempt in the preceding 6 months)
- •6-Mental retardation
- •7-Pregnant or at risk of pregnancy
- •8-Cognitive disorders such as dementia, delirium, or amnesia, traumatic brain injury
- •9-Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine)/ HIV infection / abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values
- •10-Hypersensitivity to Nigella sativa
- •11-Previous treatment with Nigella sativa in the past year
- •12-History of neuroleptic malignant syndrome
- •13-Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
排除标准
- 未提供
研究者
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