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Completed

NCT Number: NCT00217165

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.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar Depression Bipolar and Related Disorders Depression Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Taurine

Drug

taurine 2mg BID po

Primary outcomes

  1. Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)

    Time frame: 12 weeks

    MADRS and YMRS

Secondary outcomes

  1. Side-effect ratings, general health ratings

    Time frame: 12 weeks

    SF36

  2. Drop-outs due to medication changes

    Time frame: 12 weeks

    subjects leaving study before completion

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Sep 22, 2005
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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