Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression (ALIGN)

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: 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
Sponsor:
Information provided by (Responsible Party):
Valerie Taylor, Women's College Hospital

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.


Condition or disease Intervention/treatment Phase
Bipolar Depression Dietary Supplement: Bifidobacterium infantis Other: Placebo Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bifidobacterium infantis
Bifidobacterium infantis (Align) 10.00 million cfu capsule once daily
Dietary Supplement: Bifidobacterium infantis
Probiotic supplement
Other Name: ALIGN

Placebo Comparator: Placebo
Placebo capsule once daily
Other: Placebo
Placebo capsules




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Ontario
Women's college Research Institute
Toronto, Ontario, Canada, M5G1N8
Sponsors and Collaborators
Women's College Hospital
Investigators
Layout table for investigator information
Principal Investigator: Valerie Taylor, PhD Women's College Hospital

Publications:
Hamilton-Miller JMT. Probiotics in the Management of Irritable Bowel Syndrome: A Review of Clinical Trials. Microbial Ecology in Health & Disease 2001;13:212-216
Duke K, Murphy S, Smith M. Probiotic performance in IBD is not uniform: a multi-strain comparison in the lymphocyte transfer model of enterocolitis. Gastroenterology. 2004;126:A283-A284.
Spielberger CD. Manual for the State-Trait Anxiety Inventory. Corsini Encyclopedia of Psychology. 1. Palo Alto, CA: Consulting Psychologists Press; 1983
Guy W. Global Impression Scale. ECDEU Assessment Manual for Psychopharmacology-Revised. 1976.

Layout table for additonal information
Responsible Party: Valerie Taylor, Psychiatrist in Chief, Women's College Hospital
ClinicalTrials.gov Identifier: NCT02155972     History of Changes
Other Study ID Numbers: 179489
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

Keywords provided by Valerie Taylor, Women's College Hospital:
Bipolar
Depression
Probiotic
ALIGN
HAMD
STAI
YMRS
CGI
SDS
WHOQOL-BREF
C-SSRS
TSES

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders