Status:
COMPLETED
Thyroid Medication and Antidepressants for Treating Major Depression
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depression
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This study will evaluate the effectiveness of treatment with supplemental triiodothyronine (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in improving symptoms...
Detailed Description
The primary hypothesis is that triiodothyronine (Cytomel) supplementation of the antidepressant sertraline (Zoloft) will result in a greater improvement in HAM-D scores compared to placebo in the trea...
Eligibility Criteria
Inclusion
- Male or female between the ages of 18 and 60. (The upper age is limited to 60 because thyroid changes, including blunting of the TSH response to TRH occurs with age and can potentially confound the relationship between the HPT axis and MDD.)
- Primary diagnosis of unipolar Major Depressive Disorder
- HAM-D (21 item) score \>18
Exclusion
- Alcohol abuse or alcohol dependence within the past year.
- Psychoactive substance abuse or dependence within the past year.
- Clinical evidence of severe Personality Disorder that would make study participation and completion unlikely.
- ECT within the past 6 months.
- Grade I hypothyroidism defined as low thyroid hormone levels with an associated elevated TSH; hyperthyroidism defined as elevated thyroid hormone concentrations with a low TSH.
- Serious and unstable medical illnesses.
Key Trial Info
Start Date :
September 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00208702
Start Date
September 1 1996
End Date
July 1 2003
Last Update
November 17 2015
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30329