Liothyronine (T3) for Bipolar Depression

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborator: National Alliance for Research on Schizophrenia and Depression

Criteria

Inclusion Criteria:

1. Age 18-65;

2. DSM-IV diagnosis of BP I or BP II as per SCID;

3. Currently presenting with at least moderate levels of depression (HAM-D > 15;

4. 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;

5. Antidepressants and/or additional mood stabilizers are allowed, but dose should be stable for at least 2 weeks;

Exclusion Criteria:

1. Evidence of acute mania or hypomania (as measured by CARS-M > 7);

2. Abnormal (outside of lab normal range) thyroid function tests;

3. Current thyroid hormone treatment;

4. 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);

5. EKG showing rhythm other than sinus or repolarization phase abnormalities;

6. Current alcohol or substance abuse or dependence in past month as per SCID;

7. Score of 3 or more on the suicide item of the HAM-D;

8. Females who are pregnant, breastfeeding, or of childbearing age and not using adequate birth control.