The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients
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|ClinicalTrials.gov Identifier: NCT02838043|
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : June 14, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Depression Depressive Symptoms||Dietary Supplement: Probio'Stick||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||May 2018|
All participants will be experimental and receive Probio'Stick.
Dietary Supplement: Probio'Stick
A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum
- Mood [ Time Frame: 8 weeks ]Mood will be assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) with a cut-off score of 12 indicating remission.
- Anxiety [ Time Frame: 8 weeks ]Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).
- Cognition [ Time Frame: 8 weeks ]Cognition will be assess with the Digit Symbol Substitution Test (DSST).
- Sleep [ Time Frame: 8 weeks ]Sleep will be assessed objectively using a polysomnogram to look at changes electrophysiological sleep architecture after 8 weeks of treatment.
- Plasma [ Time Frame: 8 weeks ]Plasma will be analyzed to look at levels of inflammatory markers to see whether there is a decrease after 8 weeks of treatment.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Diagnosis of Major Depressive Disorder (MDD) by Mini International Neuropsychiatric Interview (MINI)
- Current depressive episode with a MADRS score of ≥ 20
- Males and females between ages 18 and 65
- Able to understand and comply with the requirements of the study
- Provision of written informed consent
- Use of any antidepressant drug
- Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
- Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period)
- Milk, yeast, or soy allergy
- History of alcohol or substance abuse in the past 6 months
- Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
- Use of any type of laxative
- Consumption of products fortified in probiotics
- Severely suicidal
- Experiencing psychosis or bipolar episode
- History of epilepsy or uncontrolled seizures
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): NCT02838043
|Kingston, Ontario, Canada, K7L 3N6|
|Providence Care - Mental Health Services|
|Kingston, Ontario, Canada, K7L 4X3|
|Principal Investigator:||Roumen Milev, PhD, MD||Queen's University|
|Responsible Party:||Dr. Roumen Milev, Psychiatrist, Queen's University|
|Other Study ID Numbers:||
|First Posted:||July 20, 2016 Key Record Dates|
|Last Update Posted:||June 14, 2019|
|Last Verified:||June 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Individual participant data will not be shared.|
Depressive Disorder, Major