The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression (ALIGN)
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|ClinicalTrials.gov Identifier: NCT02155972|
Recruitment Status : Terminated (The trial was terminated because of inability to recruit the needed number of participants)
First Posted : June 4, 2014
Last Update Posted : November 8, 2018
This is an 8-week randomized, double-blind placebo-controlled proof of concept study assessing the combination of a mood stabilizer + Align in the treatment of participants with a bipolar depressive episode. The study has two treatment arms: mood stabilizer plus placebo and mood stabilizer plus Align.
The dose of mood stabilizer will be in accordance with clinical practice guidelines and the dose for Align will be 1 capsule per day as per appropriate product dosing.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Dietary Supplement: Bifidobacterium infantis Other: Placebo||Phase 2|
Depression has emerged as the major challenge for short- and long-term management of bipolar disorder; new treatments are needed to help control this illness. Studies indicate that probiotics in the stomach improves mood and reduces anxiety symptoms lending further support to the notion that probiotic bacteria positively influence emotional states. We propose to evaluate the effectiveness of the combination of mood stabilizer and Align, a probiotic as compared to mood stabilizer monotherapy.
The primary goal of this feasibility study is to determine the safety and tolerability of Align as an add on to accepted monotherapy treatment in BD. Secondary Objective:1)To evaluate the effectiveness of the combination of mood stabilizer + Align compared to mood stabilizer monotherapy in treatment of BD. 2) to determine if Align +mood stabilizer combination will reduce anxiety symptoms.
An 8-week randomized, double-blind placebo-controlled proof of concept study assessing the combination a mood stabilizer + Align in the treatment of patients with an bipolar depressive episode. The study has two treatment arms: mood stabilizer + placebo and mood stabilizer + Align. Participants will be assessed & administered study scales at screening, baseline & weeks 2,4,6 and 8. the dose for mood stabilizer will be in accordance with clinical practice guidelines and Align - 1 capsule/day.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomized to receive either ALIGN (probiotic) or Placebo|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression: a Proof of Concept Randomized Controlled Trial|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||July 31, 2018|
Active Comparator: Bifidobacterium infantis
Bifidobacterium infantis (Align) 10.00 million cfu capsule once daily
Dietary Supplement: Bifidobacterium infantis
Other Name: ALIGN
Placebo Comparator: Placebo
Placebo capsule once daily
- safety and tolerability of Align [ Time Frame: 8 weeks ]Tolerability will be assessed using the Toronto Side Effect Scale (TSES). It is a 32-item instrument that is designed to establish incidence, frequency, and severity of central nervous system (CNS), gastrointestinal (GI), and sexual side effects. We will also assess the proportion of participants withdrawing from study due to inadequate control of depressive symptoms or treatment emergent mania
- The effectiveness of the combination of mood stabilizer + Align [ Time Frame: 8 weeks ]This will be assessed through the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to the final visit (week 8)
- evaluate the combination of mood stabilizer + Align as compared to mood stabilizer monotherapy for participants with bipolar depression with respect to anxiety symptoms and global function/overall improvement [ Time Frame: 8 weeks ]Anxiety symptoms will be assessed by looking at the mean change in the State and Trait Anxiety Index (STAI) total score, quality of life will be assessed with the World Health Organization Quality of Life (WHO-QOL) scale and global functioning will be accessed via mean change in the following: Sheehan Disability Scale (SDS) score, the clinical global impressions (CGI) severity of illness score, the CGI-Improvement scale and the CGI Participant Assessment. All measures will be evaluated looking at change from baseline to week 8
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): NCT02155972
|Women's college Research Institute|
|Toronto, Ontario, Canada, M5G1N8|
|Principal Investigator:||Valerie Taylor, PhD||Women's College Hospital|