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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00217165
First received: August 22, 2005
Last updated: April 20, 2012
Last verified: April 2012
History of Changes

August 22, 2005
April 20, 2012
April 2005
January 2010   (final data collection date for primary outcome measure)
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)
Complete list of historical versions of study NCT00217165 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Side-effect ratings
  • General health ratings (SF36)
  • Drop-outs due to medication changes
Not Provided
Not Provided
 
Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Mania
  • Bipolar Depression
Drug: taurine
taurine 2mg BID po
Placebo Comparator: 1
drug
Intervention: Drug: taurine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
January 2010   (final data collection date for primary outcome measure)

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

-
Both
18 Years to 68 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00217165
2004P-002669
No
Beth L. Murphy MD, PhD, Mclean Hospital
Mclean Hospital
Not Provided
Principal Investigator: Beth L Murphy, MD, PhD Mclean Hospital
Mclean Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP