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

NCT06754319 | Enrolling By Invitation

• 1 other identifier: SMHC-POCD-001
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder; Tic Disorder

Keywords

microbiota-gut-brain axis; pediatric OCD; microbiome

Outcome Measures

Primary Outcomes (1)

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

  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.

  Before and after treatment with SSRIs for 12 weeks

Study Arms (3)

pediatric OCD patients

Drug-naïve or drug-free pediatric patients with OCD will be enrolled in this group. After data collection, they will receive treatment with SSRIs.

pediatric OCD patients comorbid with TD

Drug-naïve or drug-free pediatric OCD patients comorbid with TD will be enrolled in this group. After data collection, they will receive treatment with SSRIs and antipsychotics.

healthy controls

Healthy children and adolescents will be enrolled in this group for data collection.

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Drug-naïve or drug-free pediatric patients with OCD, drug-naïve or drug-free pediatric OCD patients comorbid with TD, and healthy control.

You may not qualify if:

• (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.
• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal, blood, brain MRI and EEG

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Tic Disorders

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders

Study Officials

• Zhen Wang, PhD, MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 31, 2024
• Study Start: August 24, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 31, 2024

Record last verified: 2024-11

Locations

CN (1)