A Double-Blind,Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment
研究概览
简要总结
The purpose of this study is to determine whether minocycline are effective in the treatment of negative and cognitive symptoms in schizophrenia.
详细描述
Immune-related disorders have been hypothesized as etiological factors in schizophrenia.Minocycline is a second-generation tetracycline that exerts anti-inflammatory and antimicrobial effects while having a distinct neuroprotective profile.This study was performed as a double-blind, placebocontrolled,randomized evaluation of Second generation antipsychotics(SGA) and minocycline versus SGA and placebo.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female,were aged 18-40 years
- •were currently diagnosed with DSM-IV schizophrenia
- •were able to comprehend the cognition test
- •patients or guardian signed informed consent,were able to comprehend the procedure and aims of the study,agreed to join the study
- •patient's current antipsychotic medication regimen must be stable
- •must be in a stable living arrangement
排除标准
- •had ever been hypersensitivity to minocycline or tetracycline;
- •had acute,unstable,significant,or untreated medical illness besides schizophrenia
- •were pregnant or breast-feeding;
- •had a DSM-IV diagnosis of substance abuse or dependency;
- •had a tendency to suicide or Violence,self-harm;
- •had taken immunosuppressive agents in the preceding 3 months before study entry;
- •had influenza or fever in the preceding 2 weeks before study entry;
- •had a DSM-IV diagnosis of emotional psychosis,Mental retardation,etc.
- •has suicidal attempts or ideation or violent behavior within the last 12 months
- •patient has mental retardation or severe organic brain syndromes
- •treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening
研究组 & 干预措施
placebo
Subjects will be given with 200mg/day placebo(100mg,bid) and variable dose SGA. All drugs will be administered orally.
干预措施: placebo (Drug)
minocycline
Subjects will be given with 200mg/day minocycline (100mg,bid)and variable dose SGA.All drugs will be administered orally.
干预措施: minocycline (Drug)
结局指标
主要结局
Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment
时间窗: 16 weeks
The Cognitive Assessment Battery included Making Test (TMT) ,Symbol Coding,Hopkins Verbal Learning Test-Revised ,Mazes,Brief Visuospatial Memory Test-Revised ,Continuous Performance Test-Identical Pairs,Grooved Pegboard Test,Color Trail Test,Stroop Task,Verbal Fluency,Paced Auditory Serial Addition Test and Wisconsin Card Sorting Test SANS=Scale for the Assessment of Negative Symptoms
次要结局
- Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment(16 weeks)
- Cytokine Measure(16 weeks)
- metabolic index(16 weeks)
研究者
Fang Liu
Mental Health Institute of the Second Xiangya Hospital
Central South University