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Probiotic

Probiotics for Bipolar Disorder

Phase 2

Waitlist Available

Led By Faith Dickerson, PhD, MPH

Research Sponsored by Sheppard Pratt Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-65 (inclusive)

Be older than 18 years old

Must not have

Receipt of Electroconvulsive therapy (ECT) in the 30 days prior to the Visit 1/Baseline visit or planned ECT after hospital discharge

Depressive symptoms better accounted for by a diagnosis of Major Depressive Disorder, Schizoaffective disorder, Schizophrenia, or disorder(s) other than Bipolar Disorder I or II

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12, week 24

Summary

This trial will test whether taking a probiotic supplement helps people with bipolar depression who have been recently hospitalized.

Who is the study for?

This trial is for adults aged 18-65 who have been hospitalized for bipolar depression and can visit Sheppard Pratt Towson post-discharge. Participants must be fluent in English, able to consent, and diagnosed with Bipolar Disorder I or II. Exclusions include other mental disorders, substance abuse, significant medical conditions affecting the brain, pregnancy/breastfeeding women, recent investigational drug use or ECT treatment.

What is being tested?

The study aims to see if a probiotic supplement can prevent relapse in individuals recently hospitalized for bipolar depression compared to a placebo (an inert compound). The goal is to improve their clinical outcomes after discharge from the hospital.

What are the potential side effects?

While not specified here, common side effects of probiotics may include digestive discomfort such as gas or bloating. Placebos typically have no active ingredients but can cause side effects based on participants' expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had electroconvulsive therapy in the last 30 days nor plan to after leaving the hospital.

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My depression is not due to bipolar disorder but another mental health condition.

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I have a serious condition affecting my brain or thinking.

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I am experiencing mood changes due to medication or substance use.

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I have been diagnosed with celiac disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 12, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Relapse

Secondary study objectives

Brief Psychiatric Rating Scale

Columbia-Suicide Severity Rating Scale

Hamilton Depression Rating Scale

+3 more

Other study objectives

Intestinal Inflammation

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Probiotic SupplementExperimental Treatment1 Intervention

The probiotic supplement will consist of capsules containing approximately 1 billion (1.0 x 10\^9) colony forming units of the probiotic organisms, Lactobacillus rhamnosus LGG® (LGG®) and Bifidobacterium animalis subsp. lactis BB-12® (BB-12®). The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. Participants will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.

Group II: Inert CompoundPlacebo Group1 Intervention

The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic Supplement

2006

N/A

~180

0 / 6Eligibility criteria met