Back to resultsTaurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study
Primary Purpose
Bipolar Disorder, Mania, Bipolar Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
taurine
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar, mania, depression, taurine, alternative
Eligibility 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 -
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
active drug
Arm Description
cellulose
taurine
Outcomes
Primary Outcome Measures
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)
MADRS and YMRS
Secondary Outcome Measures
Side-effect ratings, general health ratings
SF36
Drop-outs due to medication changes
subjects leaving study before completion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00217165
Brief Title
Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study
Official Title
Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Mania, Bipolar Depression
Keywords
bipolar, mania, depression, taurine, alternative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
cellulose
Arm Title
active drug
Arm Type
Active Comparator
Arm Description
taurine
Intervention Type
Drug
Intervention Name(s)
taurine
Intervention Description
taurine 2mg BID po
Primary Outcome Measure Information:
Title
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)
Description
MADRS and YMRS
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Side-effect ratings, general health ratings
Description
SF36
Time Frame
12 weeks
Title
Drop-outs due to medication changes
Description
subjects leaving study before completion
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth L Murphy, MD, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mclean.org
Description
McLean Hospital website with links to research at the hospital.
Learn more about this trial
Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study
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