Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia: A Randomised Placebo-controlled Double-blind Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Positive and Negative Syndrome Scale PANSS
研究概览
简要总结
This a randomized double-blind placebo controlled trial which aims to determine the beneficial effects of minocycline augmentation to clozapine in partial responders to Treatment Resistant Schizophrenia (TRS).
详细描述
The primary objective is to determine if the addition of minocycline to Clozapine, Treatment as Usual (TAU) Improves negative symptoms and/or positive symptoms.
The secondary objectives are to determine:
- Effects on cognitive functioning.
- Effects on social functioning and quality of life.
- Safety and tolerability.
- Possible additive effects of Minocycline added to TAU
- The effect on inflammatory biomarkers associated with schizophrenia. Both pro and anti-inflammatory cytokines will be drawn at baseline and endpoint. We will test to see if minocycline is associated with improvements in abnormal cytokines as compared to placebo.
The study will be a randomized double-blind placebo controlled trial of minocycline added to clozapine (Treatment as Usual) in TRS. There will be two treatment arms: one arm receiving TAU with minocycline and the other TAU with placebo for a period of twelve weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged between 18-65 years, IQ >70 (to complete assessments) identified by treating psychiatrist.
- •Confirmation of schizophrenia by using The MINI psychiatric interview (at baseline only)
- •Assessed as competent to provide informed consent by treating psychiatrist.
- •Antipsychotic medication has remained stable 4 weeks prior to baseline *. Assessed as a partial responder to clozapine: patients prescribed clozapine at a stable therapeutic dose for a minimum of 3 months with total Positive and Negative Syndrome Schizophrenia (PANSS) score >70.
排除标准
- •Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the Tetracyclines.
- •Concomitant Penicillin therapy or concomitant anticoagulant therapy.
- •Active substance abuse (except nicotine or caffeine) or dependence within the last three months according to ICD 10 criteria.
- •Treatment with Warfarin or Lamotrigine.
- •Current or previous treatment with minocycline or other tetracycline antibiotics in the preceding three months before study entry.
- •Relevant current or past hematologic, hepatic, renal, neurological or other medical disorder that in the opinion of the principal investigator may interfere with the study.
- •Pregnant or breast-feeding females
研究组 & 干预措施
placebo
Matching placebo for Minocycline
干预措施: Minocycline (Drug)
Minocycline
Minocycline 200mg once a day orally
干预措施: Minocycline (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale PANSS
时间窗: 3 months
PANSS is an assessment measures to assess severity of symptoms of schizophrenia
次要结局
- CogState(3 Month)