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

• Sponsor: Mclean Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00217165
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 80
• Patients Per Site Per Month: 0.8

Study Details

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.

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

• Study Type: Interventional
• 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: Apr 1, 2005
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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

Primary Outcome Measures

1. Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) [12 weeks]

   MADRS and YMRS

Secondary Outcome Measures

1. Side-effect ratings, general health ratings [12 weeks]

   SF36

2. Drop-outs due to medication changes [12 weeks]

   subjects leaving study before completion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 68 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	McLean Hospital	Belmont	Massachusetts	United States	02478

Sponsors and Collaborators

• Mclean Hospital

Investigators

• Principal Investigator: Beth L Murphy, MD, PhD, Mclean Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• McLean Hospital website with links to research at the hospital.

Publications

None provided.

• Responsible Party: Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT00217165
• Other Study ID Numbers: 2004P-002669
• First Posted: Sep 22, 2005
• Last Update Posted: Mar 1, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital: bipolar; mania; depression; taurine; alternative
• Additional relevant MeSH terms: Depression; Bipolar Disorder

Study Results

No Results Posted as of Mar 1, 2019