Status:
COMPLETED
Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
In this project we aim to further refine indications for the use of the thyroid hormone - T3 for patients suffering from depression. We aim to identify a sub-group of patients who are more likely to r...
Detailed Description
The lifetime risk for major depressive disorder (MDD) is 15% in the general population. Current treatment approaches emphasize the achievement of remission. Remission implies virtual absence of depres...
Eligibility Criteria
Inclusion
- Diagnosis of Major Depressive Episode (MDE) in the context MDD according to DSM-IV criteria, without psychotic features.
- Hamilton Depression Scale (21 items, HAM-D) total \>16 with item 1 (depressed mood) \>2.
- Age 18-70 years.
- Male or female.
- Competent and willing to give written informed consent.
Exclusion
- Clinical hyper- or hypothyroidism or any other thyroid illness.
- Neurological or other medical illness that may impact upon the study or limit prescription of the study medications.
- Significant suicidal risk \[HAM-D item 3 (suicide) \>2\].
- Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
- Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
- Treatment with the antidepressant, sertraline, in current episode.
- More then one antidepressant trial or any augmentation treatment during current episode.
- Length of current episode \>12 months
- Female subjects pregnant or lactating or not using adequate contraception.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00421369
Start Date
September 1 2007
End Date
August 1 2011
Last Update
March 22 2013
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel