- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00208702
Thyroid Medication and Antidepressants for Treating Major Depression
Thyroid Axis in Major Depression
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30329
- Emory University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sertraline + triiodothyronine
|
Other Names:
Other Names:
|
Placebo Comparator: sertraline + placebo
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
MADRS score
|
Secondary Outcome Measures
Outcome Measure |
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CGI
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Boadie W Dunlop, MD, MS, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- 0431-1996
- DSIR AT-SO (NorthShore LIJ Health System)
- R01MH056946 (U.S. NIH Grant/Contract)
- 431-1996
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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