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The Gut Microbiota in Obsessive-Compulsive Disorder

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. Identifier: NCT02285699
Recruitment Status : Recruiting
First Posted : November 7, 2014
Last Update Posted : April 11, 2018
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

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 cytokine levels following 12-weeks of treatment with Selective Serotonin Reuptake Inhibitors (SSRIs).

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: SSRIs Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT02285699

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Contact: Jasmine Turna, BSc 905-921-7644
Contact: Keren Grosman Kaplan, MD 905-921-7644

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Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Jasmine Turna, BSc    905-921-7644   
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
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Principal Investigator: Michael Van Ameringen, MD, FRCPC McMaster University

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Responsible Party: McMaster University Identifier: NCT02285699     History of Changes
Other Study ID Numbers: 14-722
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: March 2018

Keywords provided by McMaster University:
Selective Serotonin Reuptake Inhibitors

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Personality Disorders
Obsessive-Compulsive Disorder
Pathologic Processes
Mental Disorders
Anxiety Disorders
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