Status:
TERMINATED
Taurine in Adolescents With Bipolar Disorder
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
Stanley Medical Research Institute
Mclean Hospital
Conditions:
Bipolar Disorder
Eligibility:
All Genders
13-18 years
Phase:
PHASE1
Brief Summary
Recently, McLean hospital conducted a 4 month taurine study which showed a reduction in mania ratings. As a follow-up to the preliminary taurine study, and complementary to the currently ongoing doubl...
Detailed Description
A cohort of adolescent (ages 13-18) patients with bipolar disorder and current manic symptoms will be approached for participation in this 3-month outpatient study. Taurine or matching placebo will be...
Eligibility Criteria
Inclusion
- Subjects must meet DSM-IV-TR criteria for bipolar disorder (type I), and current hypomania, mania, or mixed mania.
- Subjects must be between the ages of 13 through 18 years.
- Medications ("treatment-as-usual") stable x2 weeks
- Subjects must be able to assent to their participation in the study.
- Subjects must agree to avoid taking supplemental taurine (e.g. from over-the-counter preparations, energy drinks, etc).
Exclusion
- Co-morbid serious mental illness.
- Significant medical or neurological illness, including: seizure disorders, severe respiratory illness or cardiac conditions, known cerebrovascular disease, hypo- or hypertension, diabetes mellitus, and immune, endocrine, renal or hepatic dysfunction (the study team does not wish to enroll any subjects at increased risk for complications or who require additional clinical monitoring due to their medical illness).
- Pregnant subjects. It is not known what effects taurine supplementation would have on a fetus. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
- Patients who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or patients who will not likely be able to comply with the study protocol.
- Patients who meet DSM-IV-TR criteria for current substance abuse or substance dependence.
- Patients who are regularly taking supplemental taurine at the time of screening.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00391001
Start Date
February 1 2006
End Date
August 1 2007
Last Update
February 3 2010
Active Locations (2)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478
2
Cambridge Health Alliance Child & Adolescent Neuropsychiatric Research Program
Medford, Massachusetts, United States, 02155