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

February 26, 2019 updated by: Beth L. Murphy MD, PhD, Mclean Hospital

Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
cellulose
Drug: taurine
taurine 2mg BID po
Active Comparator: active drug
taurine
Drug: taurine
taurine 2mg BID po

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)
Time Frame: 12 weeks
MADRS and YMRS
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side-effect ratings, general health ratings
Time Frame: 12 weeks
SF36
12 weeks
Drop-outs due to medication changes
Time Frame: 12 weeks
subjects leaving study before completion
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004P-002669

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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