Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study. |
- Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Side-effect ratings, general health ratings (SF36) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Drop-outs due to medication changes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| 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
drug
|
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| Ages Eligible for Study: | 18 Years to 68 Years |
| Genders Eligible for Study: | Both |
| 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
-
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT00217165 History of Changes |
| Other Study ID Numbers: | 2004P-002669 |
| Study First Received: | August 22, 2005 |
| Last Updated: | April 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mclean Hospital:
|
bipolar mania depression taurine alternative |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Antimanic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013