Randomized Double-Blind Trial of Liothyronine (T3) Augmentation to Treatment as Usual vs Placebo For The Treatment of Bipolar Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression Scores
研究概览
简要总结
This study evaluates the efficacy of the thyroid hormone T3 for depression in patients with bipolar disorder. In this study patients will be randomized to receive T3 or placebo.
详细描述
Bipolar affective disorder is a debilitating illness, and is characterized by depression episodes that dominates the longitudinal course and are most difficult to treat. Controlled trials with monotherapy mood stabilizers such as lithium and valproate show little to no efficacy and antidepressants may offer no additional efficacy. Recently there has been a growing interest in the use of quetiapine in bipolar depression. However, a successful treatment may take up to 8 weeks, and full remission is achieved in only 50% of patients. Thyroid hormone augmentation strategies have been used in unipolar depression with good results, but there is a paucity of its efficacy in bipolar depression (BD). To our knowledge there are no controlled studies regarding the efficacy of thyroid augmentation in BD. The present study proposes to evaluate the efficacy of T3 as an augmentation to treatment as usual in the treatment of BD. We plan to enroll patients with bipolar disorder I or II who are currently presenting with depressive symptoms. Patients will be randomized to 2 groups - liothyronine or placebo Results will provide information on the possible role of thyroid hormone augmentation in the treatment of patients with bipolar depression, and may contribute to alleviate the burden of this disabling condition.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of BP I or BP II as per SCID;
- •Currently presenting with at least moderate levels of depression (HAM-D > 15;
- •Patient has to be on stable dose of at least one mood stabilizer (lithium, valproate, carbamazepine, lamotrigine, second generation antipsychotics) for at least 4 weeks as per history;
- •Antidepressants and/or additional mood stabilizers are allowed, but dose should be stable for at least 2 weeks;
排除标准
- •Evidence of acute mania or hypomania (as measured by CARS-M > 7);
- •Abnormal (outside of lab normal range) thyroid function tests;
- •Current thyroid hormone treatment;
- •Any medical condition considered a contraindication for treatment with T3 (i.e. history of myocardial infarction, cardiac arrhythmia, severe cardiac insufficiency, Autoimmune Thyroid Disease /Hashimoto's Thyroiditis as determined by anti-thyroid antibody testing, previous or current thyroid adenoma, hyperthyroidism);
- •EKG showing rhythm other than sinus or repolarization phase abnormalities;
- •Current alcohol or substance abuse or dependence in past month as per SCID;
- •Score of 3 or more on the suicide item of the HAM-D;
- •Females who are pregnant, breastfeeding, or of childbearing age and not using adequate birth control.
研究组 & 干预措施
1
liothyronine (T3)
干预措施: Liothyronine (T3) (Drug)
2
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression Scores
时间窗: 8 weeks
The Hamilton Rating Scale for Depression (HRSD) is a checklist of items ranked from 0-4 or 0-2, that was designed to measure the severity of depressive symptoms. The scale ranges from 0 to 50, and the following thresholds are used: very severe \>23, severe 19-22, moderate 14-18, mild 8-13 and normal ≤7.
次要结局
- Clinical Global Impression Scores(8 weeks)
- Clinician-Administered Rating Scale for Mania(8 weeks)