Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study

NCT ID: NCT00217165

Last Updated: 2019-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.

Detailed Description

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Taurine is an amino acid that has some actions similar to mood stabilizers. Taurine is widely sold as a component of over-the-counter mood enhancing agents. However, controlled studies examining the mood effects of taurine are limited. An initial study in this laboratory looked at taurine's mood effects in individuals with bipolar disorder. This follow-up study is designed to further examine taurine's effects on manic symptoms. Subjects in the current follow-up study will add taurine or placebo to their current treatment regimen. Both depressive and manic symptoms will be tracked for three months to determine whether the addition of taurine affects mood symptoms.

Conditions

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Bipolar Disorder Mania Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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placebo

cellulose

Group Type PLACEBO_COMPARATOR

taurine

Intervention Type DRUG

taurine 2mg BID po

active drug

taurine

Group Type ACTIVE_COMPARATOR

taurine

Intervention Type DRUG

taurine 2mg BID po

Interventions

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taurine

taurine 2mg BID po

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

bipolar disorder, type I bipolar disorder, type II mania hypomania mixed manic symptoms

Exclusion Criteria

significant medical or psychiatric co-morbidity pregnancy or planning pregnancy current substance abuse or dependence

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Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beth L. Murphy MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beth L Murphy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2004P-002669

Identifier Type: -

Identifier Source: org_study_id

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