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

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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

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Mania Bipolar Depression Drug: taurine Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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.
Study Start Date : April 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Taurine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo
cellulose
 Drug: taurine
taurine 2mg BID po
Active Comparator: active drug
taurine
 Drug: taurine
taurine 2mg BID po


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


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
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

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

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Responsible Party: Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00217165    
Other Study ID Numbers: 2004P-002669
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Beth L. Murphy MD, PhD, Mclean Hospital:
bipolar
mania
depression
taurine
alternative
Additional relevant MeSH terms:
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Depression
Bipolar Disorder
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders