ACTRN12613000970741终止4 期
For individuals with schizophrenia and insomnia, can melatonin and CBT improve sleep, symptoms, functioning and cognitive functions
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 50 Years(—)
- 性别
- All
入选标准
- •1. Aged 25 to 50 years.
- •2. A diagnosis of schizophrenia or schizoaffective disorder
- •3. Length of illness 10-15 years
- •4. Currently in a clinically stable condition
- •5. Current insomnia symptoms, characterised by Sleep Onset Latency (SOL) more than 30 minutes, or waking up 3 or more times per night, with an ongoing duration of the sleep problem for at least one month.
- •6. Stable medication schedule and dosage for the past month
- •7. English as a first language
- •8. Using contraceptives (applicable to females only)
- •9. Confirmation of diagnosis and suitability for the study by the potential participant’s treating psychiatrist
- •10. Able to provide informed consent
排除标准
- •1. Diagnosis or high indication of sleep-related breathing disorder (e.g. obstructive sleep apnoea), narcolepsy, nightmare disorder, periodic limb movement syndrome, or restless legs syndrome.
- •2. Suicidality.
- •3. Allergy to melatonin, corn starch, gelatine
- •4. BMI >35 (clinical obesity).
- •5. Co-morbid significant medical conditions (e.g. seizure disorder, traumatic brain injury, dementia, autoimmune disease, liver failure, or kidney failure).
- •6. Known hereditary problem of galactose intolerance, the LAPP lactase deficiency, or glucose-galactose malabsorption.
- •7. Pervasive developmental disorder or mental retardation, as defined by DSM-IV or DSM-V criteria.
- •8. Pregnant or breastfeeding (applicable to females only).
研究者
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