Bipolar Disorder, Mania, Bipolar Depression
Conditions
Keywords
bipolar, mania, depression, taurine, alternative
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.
Interventions
DRUGtaurine
taurine 2mg BID po
Sponsors
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) | 12 weeks | MADRS and YMRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side-effect ratings, general health ratings | 12 weeks | SF36 |
| Drop-outs due to medication changes | 12 weeks | subjects leaving study before completion |
Countries
United States
Outcome results
None listed