Phase 4 Sleep Disorders Trial, Recruiting NCT07076342 Sponsor: Stony Brook University Condition: Sleep Disorders
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Phase 4 Sleep Disorders Trial, Recruiting

NCT07076342
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to understand and agree to participate in the study on their own behalf
  • People who are at least 18 years old
  • People who are in generally good physical health and do not have significant ongoing medical conditions
  • People who have been diagnosed with major depressive disorder (MDD) and are currently experiencing a major depressive episode, as defined by standard psychiatric guidelines (DSM-5)
  • People whose depression score on a standard rating scale (called the MADRS) is above 29, indicating at least moderate depression
  • People whose time to fall asleep falls within a specific range — up to 128 minutes — measured consistently (confirm with trial site)

Who may not be able to join:

  • People who are currently taking antidepressants that are working effectively for them
  • People who have ever experienced psychosis at any point in their life
  • People who have had a dependence on drugs or alcohol in the last 6 months, or misuse of drugs or alcohol in the last 2 months
  • People who have a medical condition that has not been stable and well-managed for at least 3 months
  • People who have used nicotine products at any point in the past year
  • People who are currently taking medication known to affect a brain chemical called glutamate
  • People who have a sleep disorder other than insomnia, such as sleep apnea
  • People who have regularly worked night shifts or rotating shifts in the past year, or who have travelled across more than one time zone in the past 3 months — or who plan to do so during the study
  • People who use medications or substances that affect sleep, including those who consume more than 600 mg of caffeine per day
  • People for whom a PET or MRI scan would not be safe, including those who are pregnant or currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: (631)-638-2053

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Stony Brook University
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
31 March 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Sleep Latency from Baseline to 8 Weeks; Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov