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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG071522 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trazodone First | Active Comparator | Trazodone (50 mg at bedtime) and then placebo after a 4-week washout period. |
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| Placebo First | Placebo Comparator | Placebo and then Trazodone (50 mg at bedtime) after a 4-week washout period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazodone | Drug | 50mg of trazodone administered for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | 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. | 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. | 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. | 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. | 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. | Baseline and End of study, up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in memory performance between treatment arms | Comparison of means for memory performance from baseline measured in percent correct between trazodone and placebo arm. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barry Greenberg, PhD | Contact | 410-955-1696 | bgreen45@jhmi.edu | |
| Paul Rosenberg, MD | Contact | 410-550-9883 | prosenb9@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Barry Greenberg, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21205 | United States |
The Executive Committee of the study, consisting of the study PIs and the Director of the Data Coordinating Center for this study will oversee the deidentified Individual Participant Data (IPD) sharing. This will include the review of requests for trial data and samples. The Executive Committee will assure that all investigators who receive data and/or specimens are qualified investigators, with research goals consistent with those stated in the consent form. A Material Transfer Agreement (MTA) and/or Data Use Agreement (DUA) will be in place with approved requestors before any transfer of bio-samples or data. Investigators receiving the data and/or samples will be required to cite the grant in any publications generated by the data and to send a copy of all publications to the study team.
1 year after study completion
Upon approval of data analytic strategy by study team
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
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We will administer trazodone and placebo for 4 weeks each with a 4-week washout.
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Study drug will be compounded by the Investigational Drug Service (IDS) at Johns Hopkins Bayview Medical Center. The IDS will prepare blind medication using opaque capsules and randomly assign eligible participants to treatment order (ie, starting with trazodone vs. placebo treatment).
| Placebo | Drug | Placebo administered for 4 weeks. |
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| 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. |
| Baseline and End of study, up to 12 weeks |
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. |
| Baseline and End of study, up to 12 weeks |
| D011725 |
| Pyridines |