Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- slow wave sleep amount
研究概览
简要总结
30 healthy adults and 30 patients with major depressive disorder, will take part in three single-application pharmacological interventions (GHB vs. Trazodone vs. placebo p.o.) to test potential effects of these drugs on nocturnal memory consolidation. All participants will be assessed with mood state questionnaires, tests of emotional, procedural and declarative memory consolidation, polysomnography, EEG and neuroinflammatory biomarkers. At experimental nights, learning tasks are performed prior to sleep. The next morning, recalling tasks are performed. Each subject will pass through 5 study nights (1 screening, 1 adaptation and 3 experimental nights).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
healthy controls
干预措施: Placebos (Drug)
Major Depressive Disorder
干预措施: GHB (Drug)
healthy controls
干预措施: GHB (Drug)
healthy controls
干预措施: Trazodone (Drug)
Major Depressive Disorder
干预措施: Trazodone (Drug)
Major Depressive Disorder
干预措施: Placebos (Drug)
结局指标
主要结局
slow wave sleep amount
时间窗: 1 night
slow wave sleep time (minutes) during the experimental night
performance in emotional memory consolidation tasks by Emotional Picture Memory Task (EPMT)
时间窗: 10 hours after encoding
results in EPMT are measured as number of recognized pictures (1-150)
performance in procedural memory consolidation tasks by Finger Sequence-Tapping Task (FSTT)
时间窗: 10 hours after encoding
results in FSTT are measured as number of correct sequences typed in 30seconds
performance in declarative memory consolidation tasks by Paired Word List Task (PAWL)
时间窗: 10 hours after encoding
Results in PAWL are expressed as number of correct word pairs recalled (1-40).
Blood levels of Brain Derived Neurotrophic Factor (BDNF).
时间窗: 9 hours after solid drug administration
Assessed in serum samples collected by venipuncture using a butterfly needle. Unit of measure as blood concentration (ng/l or mg/ml)
homeostatic sleep pressure by Psychomotor Vigilance Task
时间窗: 10 hours after solid drug administration
Results are measured in number of correct answers
homeostatic sleep pressure by N-back Task
时间窗: 10 hours after solid drug administration
Results are measured in number of correct answers
次要结局
- Sleep quality assessed by Morgen Questionionnaire (MQ)(at 8:00 a.m. after experimental night 1,2 and 3)
- Sleep quality assessed by Karolinska Schläfrigkeitsskala (SKK)(at 8:00 a.m. after experimental night 1,2 and 3)
- Cortisol Saliva Response (CAR)(0minutes, 15minutes, 30minutes, 45minutes and 60minutes after awekening)
- Score on Positive and Negative Affect Schedule (PANAS)(8 hours after solid drug administration)
研究者
Erich Seifritz
Head of department for psychiatry, psychotherapy and psychosomatic
Psychiatric University Hospital, Zurich