Pediatric OCD and gut-brain microbiome links in kids on SSRIs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes the microbiota-gut-brain axis in pediatric OCD by integrating gut microbiota analysis, serum metabolomics, neuroimaging, and EEG before and after SSRI treatment. Participants include 7-17 year-olds with OCD, with or without tic disorders, and a healthy control group. The goal is to identify biomarkers and potential pathways that may contribute to OCD and to see how treatment influences these factors. Data will be used to explore possible new targets for intervention and to inform treatment optimization. The study is conducted at Shanghai Mental Health Center and is sponsored by the same institution.

Why it matters

Who can join: the full rules

We recruited outpatient children and adolescents with OCD confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (4th edition). The following inclusion and exclusion criteria were also applied:

Inclusion Criteria:

(1) 7-17 years old, (2) Y-BOCS score ≥16, (3) with or without a history of TD, (4) Drug-naïve or drug-free for 8 weeks, (5) Wechsler IQ score ≥ 80.

Exclusion Criteria:

* History of serious medical, neurological illness or other psychotic disorders other than OCD (tic disorder excepted).
* Previous exposure to cognitive behavioral therapy (CBT) for OCD or TD.
* serious suicide risk.
* Has taken antibiotics, probiotics, prebiotics, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within the past 8 weeks.
* Has a history of gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, constipation, hemorrhoids, or a history of gastrointestinal surgery, or has a history of autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus.
* Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.

Where it's running

• Shanghai Mental Health Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Zhen Wang, PhD, MD — Shanghai Mental Health Center
• Study coordinator: Zhen Wang, PhD, MD
• Email: wangzhen@smhc.org.cn
• Phone: +86 34773516

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.