Early Phase 1 Depression and Anxiety Trial, Recruiting NCT06784388 Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Condition: Depression and Anxiety
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Early Phase 1 Depression and Anxiety Trial, Recruiting

NCT06784388
Recruiting Early Phase 1

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:

  • You have been diagnosed with major depressive disorder (MDD) by a psychiatrist, confirmed using standard diagnostic guidelines (DSM-5)
  • Your diagnosis has been reviewed and agreed upon by two trained psychiatrists
  • You have had depression for at least 12 months and have tried at least 2 different antidepressant medications (working in different ways) at full doses without getting better — this may also include patients who have tried electroconvulsive therapy
  • Your depression is rated as severe based on a standard questionnaire score of 20 or higher (called the HAMD-17 scale)
  • Your ability to carry out daily life is rated as significantly impaired, with a score of 50 or below on a standard functioning scale (GAF)
  • You (or your legal guardian) are able to understand what the trial involves and are willing to sign a consent form to take part

Who may not be able to join:

  • You have serious or unstable heart, liver, kidney, hormone, or blood conditions, or you have symptoms of psychosis or a diagnosed personality disorder
  • You have a psychiatric condition other than depression (having generalized anxiety disorder as well is generally acceptable)
  • You have used alcohol or drugs heavily in the past 12 months, or you have a history of epilepsy or seizures with fever during childhood
  • You have attempted suicide in the past 6 months, or have made more than 2 suicide attempts in the past 2 years
  • You are currently breastfeeding, pregnant, or planning to become pregnant during the trial
  • You have any medical reason why you cannot safely have brain surgery (DBS) or an MRI scan
  • You have had 9 years of schooling or fewer
  • You are currently in hospital on an involuntary basis (i.e., admitted without your own consent)

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 5 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Phone: +86 13968055768

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
Early Phase 1
Registry
ClinicalTrials.gov
Start date
5 January 2025
Est. completion
30 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change in Hamilton Rating Scale for Depression (HAMD) score during the DBS treatment phase relative to preoperative baseline; Changes in HAMD scores during the efficacy observation phase after DBS shutdown

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: 5 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