Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Response - HAM-D-21 improvement >50% at 8 weeks
研究概览
简要总结
The purpose of this project is to determine whether concurrent treatment of patients with major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.
详细描述
AIM: To determine the therapeutic efficacy and adverse effects of triiodothyronine (T3) as a supplement to the treatment of bipolar depression (BPD) with a mood stabilizer (MS) (lithium - Li, valproic acid - VPA or carbamazepine - CBZ) and the specific serotonin reuptake inhibitor (SSRI), sertraline; and as a supplement to the treatment of unipolar depression (UPD) with sertraline.
METHOD: A random assignment, double blind, placebo-controlled trial separately evaluating patients with a) BPD who are treated with MS + sertraline + T3 or MS + sertraline + placebo and b) UPD who are treated with sertraline + T3 or sertraline + placebo, for up to 8 weeks in both cases. The design of the trial will permit both the outcome of treatment and the speed of response to be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Episode (MDE) in the context of Bipolar Disorder I or II (BPD-I or BPD-II) or Major Depressive Disorder (UPD), according to DSM-IV criteria, without psychotic features.
- •Hamilton Depression Scale (HAM-D) total >16 with item 1 (depressed mood) >
- •Age 18-70 years, male or female.
- •Competent and willing to give written informed consent.
排除标准
- •No clinical hyper- or hypothyroidism nor other thyroid illness.
- •No neurological or other physical illness that may impact upon the study or limit prescription of the study medications.
- •No lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
- •No significant suicidal risk (HAM-D item 3 (suicide) <3).
结局指标
主要结局
Response - HAM-D-21 improvement >50% at 8 weeks
Remission - final HAM-D-21 total <7 at 8 weeks
次要结局
- Rate of change in HAM-D-21 scores over 8 week treatment period