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

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.
 
ClinicalTrials.gov Identifier: NCT00217165
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital

Tracking Information
First Submitted Date  ICMJE August 22, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date March 1, 2019
Study Start Date  ICMJE April 2005
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) [ Time Frame: 12 weeks ]
MADRS and YMRS
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2005)
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • Side-effect ratings, general health ratings [ Time Frame: 12 weeks ]
    SF36
  • Drop-outs due to medication changes [ Time Frame: 12 weeks ]
    subjects leaving study before completion
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2005)
  • Side-effect ratings
  • General health ratings (SF36)
  • Drop-outs due to medication changes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study
Official Title  ICMJE Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study.
Brief Summary The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Mania
  • Bipolar Depression
Intervention  ICMJE Drug: taurine
taurine 2mg BID po
Study Arms  ICMJE
  • Placebo Comparator: placebo
    cellulose
    Intervention: Drug: taurine
  • Active Comparator: active drug
    taurine
    Intervention: Drug: taurine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2008)
60
Original Enrollment  ICMJE
 (submitted: September 15, 2005)
30
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 68 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00217165
Other Study ID Numbers  ICMJE 2004P-002669
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beth L. Murphy MD, PhD, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Beth L Murphy, MD, PhD Mclean Hospital
PRS Account Mclean Hospital
Verification Date February 2019

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