Major Depression Clinical Trial
Official title:
Thyroid Axis in Major Depression
Verified date | November 2015 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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 of major depressive disorder (MDD).
Status | Completed |
Enrollment | 153 |
Est. completion date | July 2003 |
Est. primary completion date | July 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute of Mental Health (NIMH) |
United States,
Garlow SJ, Dunlop BW, Ninan PT, Nemeroff CB. The combination of triiodothyronine (T3) and sertraline is not superior to sertraline monotherapy in the treatment of major depressive disorder. J Psychiatr Res. 2012 Nov;46(11):1406-13. doi: 10.1016/j.jpsychir — View Citation
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Primary | MADRS score | |||
Secondary | CGI |
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