CHA-IRB-0131/09/05

About this trial

Last updated 15 years ago

Study ID

CHA-IRB-0131/09/05

Status

Terminated

Type

Interventional

Phase

Phase 1

Placebo

Accepting

13 to 18 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 18 years ago

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 double-blind, placebo-controlled trial for taurine in adults with bipolar disorder, this study will target adolescent bipolar subjects (type I) with symptoms of mania or mixed mania. To our knowledge, this would be the first study to evaluate the effects of the novel compound taurine in adolescent subjects with bipolar disorder. We hypothesize there will be a positive response in some adolescents from taurine treatment, and this positive response will be greater than that expected by chance. This study may demonstrate that taurine is a well-tolerated and effective adjunct treatment for mania in bipolar disorder.

Inclusion Criteria

- 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 Criteria

- 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.

Taurine in Adolescents With Bipolar Disorder