Liothyronine (T3) for Bipolar Depression — T3  

Depression Clinical Trial

Official title: Randomized Double-Blind Trial of Liothyronine (T3) Augmentation to Treatment as Usual vs Placebo For The Treatment of Bipolar Depression

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder

• NCT number: NCT00790738
• Study type: Interventional
• Source: Northwell Health
• Status: Completed
• Phase: Phase 3
• Start date: July 2008
• Completion date: July 2012