To investigate the effect of trazodone on sleep, hippocampal-dependent memory and hippocampal excitability. The investigators hypothesize that trazodone will improve total sleep time and proportion of time in Slow Wave Sleep (SWS).
The REST trial is a randomized, placebo-controlled, double-blind crossover study of trazodone (50 mg at bedtime) in participants with Amnestic Mild Cognitive impairment (aMCI) and sleep complaints. The investigators will randomize 100 subjects and administer trazodone and placebo for 4 weeks each with a 4-week washout period in between. A 4-week washout period is more than sufficient due to trazodone's elimination half-life of 10-12 hours. The crossover design will facilitate recruitment and enable the use of the subjects as a control without requiring a parallel placebo arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGChange in total sleep duration between the treatment arms
Comparison of means of total sleep duration from baseline measured in minutes between trazodone and placebo arm.
Time frame: Baseline and End of study, up to 12 weeks
Change in Slow Wave Sleep (SWS) duration between the treatment arms
Comparison of means of SWS from baseline measured in minutes between trazodone and placebo arm.
Time frame: Baseline and End of study, up to 12 weeks
Change in SWS intensity between the treatment arms
Comparison of means of SWS intensity measured from baseline in volts squared between trazodone and placebo arm.
Time frame: Baseline and End of study, up to 12 weeks
Change in sleep onset latency between the treatment arms
Comparison of means of sleep onset latency from baseline measured in minutes between trazodone and placebo arm.
Time frame: Baseline and End of study, up to 12 weeks
Change in sleep fragmentation between the treatment arms
Comparison of means of sleep fragmentation from baseline measured in minutes between trazodone and placebo arm.
Time frame: Baseline and End of study, up to 12 weeks
Change in self reported sleep measure Pittsburgh Sleep Quality Index (PSQI) between treatment arms
Comparison of means score for PSQI from baseline between trazodone and placebo arm. A higher score means a worse outcome.
Time frame: Baseline and End of study, up to 12 weeks
Change in self reported sleep measure Epworth Sleepiness Score (ESS) between treatment arms
Comparison of means score for ESS from baseline between trazodone and placebo arm. A higher score means a worse outcome.
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Time frame: Baseline and End of study, up to 12 weeks
Change in memory performance between treatment arms
Comparison of means for memory performance from baseline measured in percent correct between trazodone and placebo arm.
Time frame: Baseline and End of study, up to 12 weeks
Change in hippocampal activation on Function Magnetic Resonance Imaging (fMRI) measures during memory functioning between treatment arms
Comparison of means of hippocampal activation on fMRI measures calculated as a beta weight reflecting relative activation during memory functioning from baseline between trazodone and placebo arm. Higher activation suggests a worse outcome.
Time frame: Baseline and End of study, up to 12 weeks