Phase 2 Depression and Anxiety Trial, Recruiting NCT07539805 Sponsor: First Affiliated Hospital of Chongqing Medical University Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT07539805
Recruiting Phase 2

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 aged 12 to 18 years
  • People who have been diagnosed with major depressive disorder (a serious form of ongoing low mood and depression) and are currently going through a depressive episode, confirmed through a structured interview process
  • People whose depression symptoms score at or above a certain level on a standard depression rating scale for children (CDRS-R score of 40 or higher) at the start of the trial
  • People whose overall illness severity scores at or above a certain level on a standard clinical rating scale (CGI-S score of 4 or higher) at the start of the trial

Who may not be able to join:

  • People who have another mental health condition diagnosed alongside their depression, except for anxiety disorders
  • People whose depression includes psychotic symptoms (such as hallucinations or delusions)
  • People who score above 13 on a scale used to measure signs of mania (elevated or unusually high mood) at the start of the trial
  • People with a history of neurological conditions (such as epilepsy or brain injury) or serious physical health conditions (such as thyroid disease, lupus, diabetes, or significant problems with the lungs, liver, or kidneys)
  • People whose depression has not responded to at least two different antidepressant medications, each taken at the right dose and for long enough to be effective
  • People who have previously not tolerated sertraline (a type of antidepressant) or did not respond to a proper course of it
  • People currently considered to be at high risk of suicide
  • People with a history of alcohol or drug abuse or dependence
  • People who are currently taking antidepressants, or have taken them recently within a specific timeframe related to how the medication clears the body (confirm with trial site)
  • People who have used probiotic foods or supplements within 2 weeks before joining the trial
  • People who have taken antibiotics or antifungal medications (taken throughout the body, not just on the skin) within 1 month before joining the trial
  • People with a history of severe food allergies or a known sensitivity to the specific probiotic ingredient (Lactobacillus crispatus) or anything else in the trial preparation
  • People who follow a vegetarian diet or other restrictive eating patterns
  • People who are pregnant or 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 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 18883368354

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
First Affiliated Hospital of Chongqing Medical University
Registry
ClinicalTrials.gov
Start date
11 June 2026
Est. completion
1 February 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change in Children's Depression Rating Scale - Revised (CDRS-R) scores

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: 14 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