Bipolar Depression Clinical Trial
Official title:
The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression: a Proof of Concept Randomized Controlled Trial
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.
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.
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