Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421369
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2007-01-11
Brief Title:
Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine T3and Reboxetine Clinical Efficacy Adverse Effects and Predictors of Response
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine T3and Reboxetine Clinical Efficacy Adverse Effects and Predictors of Response
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 respond to T3 and establish the time in the treatment course when T3 should be added The results of this project could have significant direct clinical implications
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 depressive symptoms and is associated with better function and a better overall prognosis than response which is usually defined as a 50 reduction in symptom severity Sixty percent or more of patients treated optimally with antidepressants remain un-remitted and will need additional treatment A potentially effective but under-exploited strategy to augment antidepressant effects is concurrent administration of the thyroid hormone triiodothyronine T3 We previously demonstrated the clinical efficacy and safety of T3 administered concurrently with the SSRI sertraline in the context of a randomized double-blind placebo-controlled trial Although all the patients were euthyroid remission rates were significantly higher in the sertraline plus T3 group and were associated with significantly lower baseline T3 values and a significant decrease in serum thyroid stimulating hormone TSH values during the course of treatment
The study aims to
Delineate a sub-population of depressed patients treated with sertraline who are more likely to respond to T3 augmentation on the basis of thyroid function and genetic variation in thyroid pathway genes
Investigate the appropriate timing for the addition of T3
Assess the efficacy of reboxetine a specific noradrenaline reuptake inhibitor as a further supplement to the treatment of un-remitted patients The results of this study could have a significant direct clinical impact on the pharmacological treatment of MDD
The study aims to
Delineate a sub-population of depressed patients treated with sertraline who are more likely to respond to T3 augmentation on the basis of thyroid function and genetic variation in thyroid pathway genes
Investigate the appropriate timing for the addition of T3
Assess the efficacy of reboxetine a specific noradrenaline reuptake inhibitor as a further supplement to the treatment of un-remitted patients The results of this study could have a significant direct clinical impact on the pharmacological treatment of MDD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None