Back to resultsThyroid Medication and Antidepressants for Treating Major Depression
Primary Purpose
Major Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Triiodothyronine
Placebo
Sertraline
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring Major Depressive Disorder, Mental Health, Depression
Eligibility Criteria
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.
Sites / Locations
- Emory University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
sertraline + triiodothyronine
sertraline + placebo
Arm Description
Outcomes
Primary Outcome Measures
MADRS score
Secondary Outcome Measures
CGI
Full Information
NCT ID
NCT00208702
First Posted
September 13, 2005
Last Updated
November 16, 2015
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00208702
Brief Title
Thyroid Medication and Antidepressants for Treating Major Depression
Official Title
Thyroid Axis in Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 of major depressive disorder (MDD).
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 treatment of Major Depressive Disorder (MDD).
The goals of this proposal are to examine the relationship between Major Depressive Disorder (MDD) and abnormalities of the hypothalamic pituitary thyroid (HPT) axis. This protocol will systematically examine the value of supplemental triiodothyronine (T3, Cytomel) with sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) in the treatment of MDD. The focus will be on two overlapping populations: 1) those with evidence of HPT abnormalities, and 2) those who did not respond to a previous adequate SSRI trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major Depressive Disorder, Mental Health, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sertraline + triiodothyronine
Arm Type
Experimental
Arm Title
sertraline + placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Triiodothyronine
Other Intervention Name(s)
Cytomel
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Primary Outcome Measure Information:
Title
MADRS score
Secondary Outcome Measure Information:
Title
CGI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boadie W Dunlop, MD, MS
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22964160
Citation
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.jpsychires.2012.08.009. Epub 2012 Sep 7.
Results Reference
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Thyroid Medication and Antidepressants for Treating Major Depression
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