Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study in Adolescents With Bipolar Disorder
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Young Mania Rating Scale (YMRS; 11 item structured interview; Young et al 1978).
研究概览
简要总结
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.
详细描述
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 administered orally, in capsules, and added to whatever medication(s) the patients are receiving from their clinicians. The specific medications and dosages will be determined solely by the subjects' non-study clinicians ("treatment-as-usual"). During the 3 months of the study, subjects will be required to keep their medications nearly constant (minor dosage adjustments for side-effects or to maintain therapeutic levels will be permitted) for the duration of the trial. Since taurine will be an adjunctive therapy, patients currently taking mood stabilizers can continue to do so. The research team will work closely with the subject and their outpatient clinician(s) to coordinate the medication issues. The results from standard rating scales for bipolar disorder research will be compared between the group receiving the taurine and the group receiving placebo.
The sample will include thirty adolescent (ages 13-18) outpatients with bipolar disorder, type I. The study will be 3 months long.
Study Drugs: The cohort will be randomized to receive either taurine or matching placebo (microcellulose). Taurine and placebo will be provided in 500 mg vegetable capsules.
Follow-up visits and clinical ratings:
During the baseline visit, a detailed psychiatric and medical history will be obtained. The adolescent will start study medicine at that time. The following standard rating scales will be performed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
1
干预措施: Taurine (Drug)
2
干预措施: Taurine (Drug)
结局指标
主要结局
Young Mania Rating Scale (YMRS; 11 item structured interview; Young et al 1978).
时间窗: weekly
次要结局
未报告次要终点