NCT04350567Completed
Sleep/Wake Cycle and Depression: An Imaging and Treatment Study
Role of the Metabotropic Glutamate Receptor Subtype 5 in Circadian Rhythm Misalignment and Depression: Implications for Treatment
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
16.2 million American adults are affected by depression each year. The investigators are studying the relationship between sleep/wake cycle and depression. Mounting evidence suggests that abnormalities in circadian rhythms (biological changes that happen over the course of the day or night) are related to mood disorders. This may explain why people with depression frequently suffer with sleeping problems. The purpose of this study is to understand how circadian (sleep/wake) rhythms may be affected in depression and the best way to improve depression caused in this way. This will be performed by comparing circadian (sleep/wake) rhythms in people with and without depression. The study involves being kept awake for one night. For depressed individuals, this technique will likely result in a brief (\<1 day) improvement in depression. Following this study, participants with depression will be offered antidepressant medication at no cost. During the study, the investigators use brain scans to learn more about brain chemistry in health and depression.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 17 Mar 2020
- Start date
- 1 Sept 2020
- Primary completion date
- 31 May 2025
- Lead sponsor
- Stony Brook University
- Diseases
- Depression
- NCT number
- NCT04350567
What you commit to
- Study type: Interventional
- Participants enrolled: 61
- From 1 Sept 2020 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unlikely to tolerate medication washout or the drug free period following washout (depressed participants only)
- Inability to maintain in bed and out of bed (regardless of sleep time, for depressed individuals) or sleep and wake times (for non-depressed individuals) to within \~30 min for a week before each overnight visit (will be measured by actigraphy and/or other measurements)
- Inability to abstain from medications that will affect glutamate levels or circadian rhythms, including stimulants, anti-epileptics, antidepressants, beta-blockers, hypnotics (including benzodiazepines), melatonin, or medications with glutamateric or GABAergic modes of action within 4 weeks before the first overnight visit as well as throughout the study
- Inability to abstain from nicotine within 4 weeks before the first overnight visit as well as throughout the study
- Inability to reduce use of alcohol to \<= \~5 drinks per week from 4 weeks before the first overnight visit and throughout the study and to completely abstain from alcohol within 24 hours of any overnight visit
- Inability to abstain from significant substance use (including cannabis) within 4 weeks before the first overnight visit as well as throughout the study
- Planned intermittent fasting or calorie restricted diet within 4 weeks before the first overnight visit as well as throughout the study
- Any MRI contraindications, including metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI
- Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is currently breastfeeding
Other illness
- Significant active physical illness or neurological deficit that may affect brain function or imaging
- A disease, job or life circumstance that creates an irregular circadian rhythm anticipated during the study
Other
- Participant considered at significant risk for suicide
- Current psychosis
- ECT within 4 weeks of the first overnight visit
- Inability to reduce caffeine intake to \<= \~300 mg of caffeine (\~2.5 cups of coffee or equivalents) daily within 4 weeks of the first overnight visit as well as throughout the study
- For females: Pregnancy within the past year, currently lactating; planning to conceive during the course of study participation, or abortion in the past two months
Who the study is looking for
- Consent form signed
- Capacity to give informed consent
- Age 18 years or older (inclusive)
- Diagnosis of MDD and currently in a major depressive episode (depressed participants only)
- Score of at least twenty-nine on the MADRS (depressed participants only)
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stony Brook University Hospital Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.