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

Sponsor:	Mclean Hospital
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00217165

Purpose

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

Condition	Intervention	Phase
Bipolar Disorder Mania Bipolar Depression	Drug: taurine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study.

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Taurine

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:

Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side-effect ratings, general health ratings (SF36) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Drop-outs due to medication changes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator drug	Drug: taurine taurine 2mg BID po

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.

Eligibility

Ages Eligible for Study:	18 Years to 68 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217165

Contacts

Contact: Sue B

617-855-3184

Locations

United States, Massachusetts
McLean Hospital	Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Jenny K 617-855-2779
Contact: Jin K 617-855-2540
Principal Investigator: Beth L Murphy, MD, PhD

Sponsors and Collaborators

Mclean Hospital

Investigators

Principal Investigator:

Beth L Murphy, MD, PhD

Mclean Hospital

More Information

Additional Information:

McLean Hospital website with links to research at the hospital. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	McLean Hospital ( Beth Murphy MD, PhD )
Study ID Numbers:	2004P-002669
Study First Received:	August 22, 2005
Last Updated:	January 12, 2010
ClinicalTrials.gov Identifier:	NCT00217165 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mclean Hospital:

bipolar
mania
depression
taurine
alternative

Additional relevant MeSH terms:

Depression
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder
Antimanic Agents

Pharmacologic Actions
Behavioral Symptoms
Affective Disorders, Psychotic
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010