Clinical trial NCT02155972: The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression
Official title: The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression: a Proof of Concept Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bipolar Depression
Keywords: Bipolar
Depression
Probiotic
ALIGN
HAMD
STAI
YMRS
CGI
SDS
WHOQOL-BREF
C-SSRS
TSES
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to receive either ALIGN (probiotic) or Placebo
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent form. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English
* Male and Female participants 18 - 65 years of age ,inclusive, at the time of screening
* Demonstrates a diagnosis of bipolar depression (type I or II) according to the Mini International Neuropsychiatric interview (MINI)
* Is not hospitalized or institutionalized (outpatient) at the time of screening
* Have been on a stable (unchanged) and adequate dose of one of the permissible medications for at least 8 weeks prior to screening (lithium, valproate/divalproex, carbamazepine, lamotrigine, quetiapine/quetiapine XR, olanzapine, or risperidone)
* Demonstrates a maximum HAM-D score of 24 at screening and baseline visits
* Female participants Must:

Not be breast feeding Not be pregnant or seeking to get pregnant during the course of this study. Be menopausal or using an acceptable method of birth control (implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner)

Exclusion Criteria:

* Demonstrates or reports a history of any of the DSM-IV criteria for classification of substance abuse/dependence disorders in the past year.
* Demonstrates the presence of active eating disorders, schizophrenia or schizoaffective disorder
* Demonstrates current psychotic symptoms
* Demonstrates a Young Mania Rating Scale (YMRS) score of \>12 at screening
* Demonstrates active suicidality based on the C-SSR scale
* Reports using any potent cytochrome P450 inhibitors (such as chloramphenicol, antifungal agents) during the 14 days prior to screening
* Reports a history of electroconvulsive therapy (ECT) during the 90 days prior to screening
* Reports using Align or any other probiotic supplement within the last year prior to screening
* Reports a history of allergic response(s) to components of Align (such as Bifidobacterioum), or any other related drug.
* Reports a presence or history of any medical conditions that would affect drug pharmacokinetics (gastrointestinal conditions such as chroris or colitus).
* Reports a history of any immunocompromising condition (such as HIV, lymphoma, patients undergoing long-term corticosteroid treatment)
* Currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
* Reports use of other natural health products (in addition to probiotics) that affect depression (such as St. Johns Wart, Tryptophan) within the last 6 months prior to screening
* Reports frequent consumption of foods rich in / enriched with probiotics (e.g. yoghurt, drinks, e.t.c).

Primary outcomes:
measure: safety and tolerability of Align
timeFrame: 8 weeks
Secondary outcomes:
measure: The effectiveness of the combination of mood stabilizer + Align
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's college Research Institute
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Valerie Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
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