The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02838043|
Recruitment Status : Active, not recruiting
First Posted : July 20, 2016
Last Update Posted : December 24, 2018
|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|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
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.
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|