The Gut Microbiota in Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SSRIs
Sponsored by
About this trial
This is an interventional other trial for Obsessive-Compulsive Disorder focused on measuring Selective Serotonin Reuptake Inhibitors
Eligibility 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.
Sites / Locations
- MacAnxiety Research Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SSRI treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Yale Brown Obsessive Compulsive Scale
Clinical Global Impression - Improvement
Secondary Outcome Measures
Obsessive-Compulsive Inventory - Revised (OCI-R)
Dutch Dimensional Obsessive Compulsive Scale (DDOCS)
Depression Anxiety Stress Scale (DASS-21)
Anti-Cancer Council of Victoria Food Frequency Questionnaire
Full Information
NCT ID
NCT02285699
First Posted
November 5, 2014
Last Updated
August 31, 2020
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02285699
Brief Title
The Gut Microbiota in Obsessive-Compulsive Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
March 1, 2016 (Actual)
Study Completion Date
March 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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 Neuropsychiatric Interview (MINI) to determine whether criteria for a primary OCD diagnosis is met alongside any additional comorbid disorders. Healthy controls will also be assessed using the MINI to confirm the absence of any psychiatric disorders. Participants will complete a number of clinician and self-rated symptom severity scales as listed below:
a. Yale Brown Obsessive-Compulsive Scale (YBOCS) - Clinician-rated b. Montgomery Asberg Depression Rating Scale (MADRS) - Clinician-rated c. Obsessive-Compulsive Inventory - Revised (OCI-R) - Self-rated d. Depression Anxiety Stress Scale (DASS-21) - Self-rated e. Dutch Dimensional Obsessive-Compulsive Scale (DDOCS) - Self-rated
2. They will also complete additional questionnaires pertaining to their diet and bowel functioning:
Gastrointestinal Symptom Rating Scale (GSRS)
Short-form Leeds Dyspepsia Questionnaire (SF-LDQ)
Rome III criteria for Irritable Bowel Syndrome
Assessment of diet using the Anti-Cancer Council of Victoria Food Frequency Questionnaire (ACCVFFQ).
3. Subjects will also be asked to provide background information regarding travel in the past 4 months and current place (and duration) of residence as these factors may potentially affect the microbiome profile.
4. Patients will be weighed and their height measured to determine body mass index (BMI).
5. Those who meet study criteria will be provided with a collection kit and instructed on appropriate fecal sample collection. The sample should be the first bowel movement of the day. Participants will have a blood sample drawn to examine serum levels of IL-6, TNF- α and CRP.
Fecal Sample Collection Patients and healthy controls will collect fecal samples at home using the investigators well-established protocol. Stool samples will be collected and transferred to a sterile screw capped sample jar and placed in a standard household freezer. The samples will be transported on the cooling pad to study personnel at the MacAnxiety Research Centre where they will be stored in a study freezer before transport to McMaster University. In the laboratory, part of the stool sample will be transferred into four 2-ml cryovials and snap frozen using liquid nitrogen for molecular analysis of microbiota.
PHASE II:
Participants interested in pharmacological treatment for their OCD symptoms after completing phase 1, will have the option to continue into phase 2 of the study. Here participants will receive 12-weeks of standard open-label treatment with an SSRI. During this 12 week period, subjects will attend 5 additional visits. The first 3 visits will occur once every 2 weeks while visits 4 and 5 will occur at weeks 8 and 12 of treatment. As per the APA guidelines (APA 2007) participants will receive 4-6 weeks of treatment at the optimal dosage.
The visits will be organized as follows:
Baseline Visit: This visit will correspond with the procedures outlined in Part One of the study. Participants will also begin open-label SSRI treatment at this visit, once blood and stool samples have been collected. In this Phase the clinician will also complete the following scales at each visit:
i. Clinical Global Impression - Improvement (CGI-I) - Clinician-rated ii. Clinical Global Impression - Severity (CGI-S) - Clinician-rated
During each visit (visits 2-5) participants will be assessed by the treating physician to determine whether modifications to SSRI dosage are warranted. Dosage increases will be based on response to present dose and experienced side effects. The clinician-rated Y-BOCS and MADRS will also be completed at each visit. Patients will complete the ACCVFFQ at visit 3 (week 4). The medication dosage will not be increased after visit 5.
Visit 6 (week 12): Participants will undergo usual assessment, treatment response will also be determined at this visit (CGI-I score ≤ 2 as well as a 30% drop in YBOCS score). Participants will be provided with a collection kit and instructed on appropriate fecal sample collection (as outlined above). The sample collected will be the first bowel movement of the day. Blood samples will be drawn at a local Gamma-Dynacare lab to examine serum levels of IL-6, TNF α and CRP. Patient diet will also be assessed using the ACCVFFQ.
After returning the fecal sample and completing the bloodwork, participants will begin a 2-week taper period where the subject will be instructed to gradually reduce the dosage of the prescribed SSRI. Participants will have the option to continue treatment in the situation where they wish to do so.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Selective Serotonin Reuptake Inhibitors
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SSRI treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SSRIs
Other Intervention Name(s)
Fluoxetine, Paroxetine, Fluvoxamine, Escitalopram, Citalopram, Sertraline
Intervention Description
12-weeks of standard SSRi treatment for those interested in Phase II of the study.
Primary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale
Time Frame
12 weeks
Title
Clinical Global Impression - Improvement
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Obsessive-Compulsive Inventory - Revised (OCI-R)
Time Frame
12 weeks
Title
Dutch Dimensional Obsessive Compulsive Scale (DDOCS)
Time Frame
12 weeks
Title
Depression Anxiety Stress Scale (DASS-21)
Time Frame
12 weeks
Title
Anti-Cancer Council of Victoria Food Frequency Questionnaire
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Van Ameringen, MD, FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MacAnxiety Research Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1B7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
32307692
Citation
Turna J, Grosman Kaplan K, Anglin R, Patterson B, Soreni N, Bercik P, Surette MG, Van Ameringen M. The gut microbiome and inflammation in obsessive-compulsive disorder patients compared to age- and sex-matched controls: a pilot study. Acta Psychiatr Scand. 2020 Oct;142(4):337-347. doi: 10.1111/acps.13175. Epub 2020 May 18.
Results Reference
derived
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The Gut Microbiota in Obsessive-Compulsive Disorder
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