Status:
COMPLETED
Liothyronine (T3) for Bipolar Depression
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Depression
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
Detailed 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 monothe...
Eligibility Criteria
Inclusion
- Age 18-65;
- 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;
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00790738
Start Date
July 1 2008
End Date
July 1 2012
Last Update
July 2 2015
Active Locations (1)
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1
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004