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The Gut Microbiota in Obsessive-Compulsive Disorder

This study is currently recruiting participants.
Verified December 2016 by M. Van Ameringen, McMaster University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285699
First Posted: November 7, 2014
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
M. Van Ameringen, McMaster University
  Purpose
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 cytokine levels following 12-weeks of treatment with Selective Serotonin Reuptake Inhibitors (SSRIs).

Condition Intervention
Obsessive-Compulsive Disorder Drug: SSRIs

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Pilot Study Examining the Gut Microbiota in Patients With Obsessive-Compulsive Disorder vs. Healthy Controls and Following 12-weeks of Open-label Selective Serotonin Reuptake Inhibitors Treatment

Resource links provided by NLM:


Further study details as provided by M. Van Ameringen, McMaster University:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Scale [ Time Frame: 12 weeks ]
  • Clinical Global Impression - Improvement [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Obsessive-Compulsive Inventory - Revised (OCI-R) [ Time Frame: 12 weeks ]
  • Dutch Dimensional Obsessive Compulsive Scale (DDOCS) [ Time Frame: 12 weeks ]
  • Depression Anxiety Stress Scale (DASS-21) [ Time Frame: 12 weeks ]
  • Anti-Cancer Council of Victoria Food Frequency Questionnaire [ Time Frame: 12 weeks ]

Estimated Enrollment: 25
Study Start Date: November 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SSRI treatment
The intervention only applies to Phase II of the proposed study. Individuals in the OCD group will be offered 12-weeks of standard SSRI treatment ti determine whether 12-weeks of treatment results in a change of the gut microbiota/inflammatory markers.
Drug: SSRIs
12-weeks of standard SSRi treatment for those interested in Phase II of the study.
Other Names:
  • Fluoxetine
  • Paroxetine
  • Fluvoxamine
  • Escitalopram
  • Citalopram
  • Sertraline

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with a primary diagnosis of OCD (DSM 5) according to the MINI
  • Y-BOCS score of ≥20.
  • MADRS < 18

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285699


Contacts
Contact: Jasmine Turna, BSc 905-921-7644 turnaj@mcmaster.ca
Contact: Keren Grosman Kaplan, MD 905-921-7644 grosmak@mcmaster.ca

Locations
Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Jasmine Turna, BSc    905-921-7644    turnaj@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Michael Van Ameringen, MD, FRCPC McMaster University
  More Information

Responsible Party: M. Van Ameringen, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT02285699     History of Changes
Other Study ID Numbers: 14-722
First Submitted: November 5, 2014
First Posted: November 7, 2014
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by M. Van Ameringen, McMaster University:
Selective Serotonin Reuptake Inhibitors

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Serotonin
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators