NCT01133080Unknown4 期
Minocycline as an Adjunctive Therapy for Schizophrenia: a Randomized Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Positive symptoms
研究概览
简要总结
Double - Blind, Randomized, single centered study. The purpose of this study is to assess the feasibility of minocycline vs. placebo, added to atypical antipsychotic medications, for positive symptoms in adults suffering from schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 20-65 years of age.
- •Primary DSM-IV diagnosis of Schizophrenia based on SCID for schizophrenia and confirmed by two senior psychiatrists.
- •Patients who scored "moderate" (4) or higher on at least three of seven positive items in PANSS
- •Initiated on treatment with atypical anti-psychotic medication.
- •Capable and willing to provide informed consent
- •Able to adhere to the treatment schedule
- •Able to read, hear, write and speak the local language.
- •Has signed a written informed consent to participate in the study
排除标准
- •Patients with acute, unstable, significant, or untreated medical illness besides schizophrenia including alcohol and drug dependence, or depression.
- •Current suicidal ideation or history of a suicide attempt in the past 3 years
- •Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse. or women who are breastfeeding
- •Subjects who were taking a known contraindication to minocycline treatment.
- •Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
- •Subjects who were under compulsory hospitalization.
研究组 & 干预措施
Minocycline
Experimental
干预措施: Minocycline (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Positive symptoms
时间窗: from baseline to the end of the study (day 56)
Positive symptoms: The change in Scale for the Positive and Negative Syndrome Scale (PANSS) score from baseline to the end of the study and the change in Clinical Global Impression Scale (CGI).
次要结局
未报告次要终点
研究者
研究点 (2)
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