Phase 4 Sleep Disorders Trial, Recruiting NCT06740188 Sponsor: Tongji University Condition: Sleep Disorders
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Phase 4 Sleep Disorders Trial, Recruiting

NCT06740188
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 either currently admitted to hospital or attending as an outpatient
  • People aged 18 to 65 years old
  • People who have been formally diagnosed with both depression and non-organic insomnia (sleep problems not caused by a physical condition) according to the DSM-5 diagnostic guidelines
  • People who score 17 or higher on a standard depression rating scale called the Hamilton Depression Rating Scale (17-item version)
  • People who score 16 or higher on a standard sleep quality questionnaire called the Pittsburgh Sleep Quality Index
  • People who have never previously taken antidepressant or sleep medication
  • People who have adequate vision and hearing, and no difficulties with understanding
  • People who are able to complete questionnaires independently
  • People who have completed at least a primary school level of education
  • People who are able to provide written consent to participate (or, if a person is temporarily unable to make decisions during their illness, written consent from their legal guardian)

Who may not be able to join:

  • People who have other mental health conditions such as schizophrenia, bipolar disorder, intellectual disability, developmental disorders, delirium, dementia, cognitive impairment, or alcohol dependence
  • People who have serious physical health conditions such as diabetes, thyroid disease, high blood pressure, heart or cardiovascular disease, head injury, or a history of stroke or brain bleeding
  • People who have a condition called narrow-angle glaucoma (a type of eye condition involving pressure in the eye)
  • People with a history of epilepsy or seizures associated with fever
  • People with a history of illicit drug use
  • People who test positive for syphilis or HIV
  • People who are currently assessed as having a serious risk of suicide, or who are severely agitated
  • Women who are pregnant, breastfeeding, or planning to become pregnant in the near future
  • People whose blood tests show signs of liver or kidney problems
  • People who have other medical reasons that would make taking antidepressant medication inadvisable (confirm with trial site)

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 6 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: 86+2168306699

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
Tongji University
Registry
ClinicalTrials.gov
Start date
1 January 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Sleep structure staging

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: 6 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