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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00217165
First Posted: September 22, 2005
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study.

Resource links provided by NLM:


Further study details as provided by Beth L. Murphy MD, PhD, Mclean Hospital:

Primary Outcome Measures:
  • Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Side-effect ratings, general health ratings (SF36) [ Time Frame: 12 weeks ]
  • Drop-outs due to medication changes [ Time Frame: 12 weeks ]

Enrollment: 60
Study Start Date: April 2005
Study Completion Date: December 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
cellulose
Drug: taurine
taurine 2mg BID po
Active Comparator: 2
taurine
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217165


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Beth L Murphy, MD, PhD Mclean Hospital
  More Information

Additional Information:
Responsible Party: Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00217165     History of Changes
Other Study ID Numbers: 2004P-002669
First Submitted: August 22, 2005
First Posted: September 22, 2005
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by Beth L. Murphy MD, PhD, Mclean Hospital:
bipolar
mania
depression
taurine
alternative

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs