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临床试验/ACTRN12613000970741
ACTRN12613000970741终止4 期

For individuals with schizophrenia and insomnia, can melatonin and CBT improve sleep, symptoms, functioning and cognitive functions

The University of Western Australia0 个研究点目标入组 13 人开始时间: 2013年8月30日最近更新:
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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