ISRCTN32434568已完成未知
OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia: A Large Simple 2x2 Factorial Trial
niversity of Oxford (UK)0 个研究点目标入组 334 人开始时间: 2010年1月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 334
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
- 性别
- All
入选标准
- •1. Diagnosis of DSM-IV schizophrenia
- •2. Active psychotic symptoms - i.e. hallucinations, delusions, thought disorder
- •3. Inpatient or outpatient
- •4. Aged 18 to 70 years.
- •5. Able and willing to consent to participate
- •6. Minimum score on PANSS 60
- •7. Drug treatment stable
- •8. Currently taking effective dose of antipsychotic
- •9. Adjunctive mirtazapine appears reasonable and both investigator and patient are uncertain whether it will offer any benefit
- •10. Clinically appropriate to change or augment treatment. Participants for whom random allocation of folic acid or placebo is not appropriate will be allocated mirtazapine or placebo only.
- •Ammended 22/09/10:
- •4. 16-70 years
排除标准
- •1. Not meeting criteria for current manic episode including schizoaffective disorder
- •2. No antidepressant treatment within last two weeks and not considering treatment for depression
- •3. Not taking clozapine
- •4. No contraindication to investigational medicinal products
- •5. Not pregnant, breast-feeding or planning a pregnancy
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