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NCT00217165 Clinical Trial

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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00217165
Other study ID # 2004P-002669
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2005
Est. completion date December 2011

Study information
Verified date February 2019
Source Mclean Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2011
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 68 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• taurine
taurine 2mg BID po

Locations
Country Name City State
United States McLean Hospital Belmont Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) MADRS and YMRS 12 weeks
Secondary Side-effect ratings, general health ratings SF36 12 weeks
Secondary Drop-outs due to medication changes subjects leaving study before completion 12 weeks
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