Status:
COMPLETED
The Gut Microbiota in Obsessive-Compulsive Disorder
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will examine the gut microbiota and serum inflammatory markers in patients with Obsessive-Compulsive Disorder vs. healthy controls. Phase II of the study will examine the gut microbiota and...
Detailed Description
Phase I of the study will involve 25 healthy controls (no anxiety or mood disorders) and 25 outpatients with primary DSM 5 OCD. Participants ages 18-65 will be assessed using the Mini International Ne...
Eligibility Criteria
Inclusion
- Patients with a primary diagnosis of OCD (DSM 5) according to the MINI
- Y-BOCS score of ≥20.
- MADRS \< 18
Exclusion
- Participants with current Major Depressive Disorder.
- Patients with significant suicidal ideation (MADRS item 10 ≥ 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Individuals with current autoimmune disorders (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.), inflammatory bowel disease, diabetes.
- Current use of any psychotropic agent SSRIs, benzodiazepines, MAO Inhibitors, tricyclic antidepressants. Past pharmacotherapy is permitted if treatment ended 3 months prior to sampling.
- Current use of herbal psychoactive treatments i.e. St. John's Wort, Kava Kava, Chamomile Extract, Valeria. Past use is permitted if treatment ended 3 months prior to sampling.
- Participants receiving current psychotherapy, including cognitive behavioural therapy for an anxiety or mood disorder 3 months prior to sampling.
- Patients who currently fulfill criteria for a lifetime history of bipolar disorder, history of drug abuse, a history of schizophrenia or other psychotic disorders, delirium, dementia and amnesic and other cognitive disorders, or are in a current agitated state.
- Patients meeting criteria for current substance use disorder.
- A body mass index (BMI) \>30
- Antibiotic or probiotic use within 8 weeks of sampling. Patients beginning antibiotic treatment or probiotic use during Phase II of the study will be excluded.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02285699
Start Date
November 1 2014
End Date
March 1 2016
Last Update
September 2 2020
Active Locations (1)
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1
MacAnxiety Research Centre
Hamilton, Ontario, Canada, L8S 1B7