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Clinical Trials/NCT06754319
NCT06754319
Enrolling By Invitation
Not Applicable

Pathogenesis of Pediatric Obsessive-compulsive Disorder: Based on the Microbiota-gut-brain Axis

Shanghai Mental Health Center1 site in 1 country125 target enrollmentAugust 24, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obsessive-Compulsive Disorder
Sponsor
Shanghai Mental Health Center
Enrollment
125
Locations
1
Primary Endpoint
Changes in the diversity and composition of the microbiome before and after drug treatment.
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief Summary

This study aims to investigate the characteristics of the microbiota-gut-brain axis in pediatric patients with obsessive-compulsive disorder (OCD) through performing an integrated analysis of gut microbiota, serum metabolomics, neuroimaging and electroencephalography (EEG), conducted before and after treatment with selective serotonin reuptake inhibitors (SSRIs). The results will be compared with those of pediatric OCD paitents comorbid with tic disorder (TD) and healthy controls. The findings are expected to further elucidate the potential pathogenesis of OCD, providing a theoretical basis for identifying novel clinical intervention targets and optimizing treatment strategies.

Registry
clinicaltrials.gov
Start Date
August 24, 2024
End Date
December 31, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhen Wang

vice-president

Shanghai Mental Health Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in the diversity and composition of the microbiome before and after drug treatment.

Time Frame: Before and after treatment with SSRIs for 12 weeks

The diversity (including alpha-diversity and beta-diversity) and composition will be measured in OCD patients and OCD patients with TD before and after drug treatment, and the results will be compared with those of healthy controls.

Study Sites (1)

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