Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386841
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2006-10-11
Brief Title:
Outcome Following Antidepressant Treatment on Possible Endo-Phenotypes for Major Depression
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Associations Between Gene-Polymorphisms Endo-Phenotypes for Depression and Antidepressive Treatment AGENDA
Status:
COMPLETED
Status Verified Date:
2009-06
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:
The purpose of this study is to determine whether outcome following antidepressant treatment can be used as a tool to evaluate endo-phenotypes for depression
Detailed Description:
The research in depression has for some years focused at the identification of endo-phenotypes Endo-phenotypes are heritable biological or psychological markers which are more commonly found in patients and their healthy relatives than in the general population
Recent studies point at disturbed regulation of the hypothalamic-pituitary-adrenocortical HPA system as a possible endo-phenotype for depression
The hypothesis of AGENDA are that endo-phenotypes are affected by treatment with antidepressants in healthy first degree relatives
AGENDA is a four week randomized placebo-controlled double-blind trial in which first degree relatives of patients with the diagnosis of depression are randomised in to two groups which are treated with either placebo or antidepressant medicine Cipralex We expect to include 80 healthy subjects with the predisposition for depression since one of their parents or siblings recently was treated for depression
The subjects will be examined before and after four weeks of treatment by a thorough interview concerning psychiatric symptoms SCAN including depressive symptoms personality perceived stress and cognitive function The effect of antidepressant on stress is measured with saliva-cortisol and by the response to the combined dexamethasone corticotropin-releasing CRH hormone test Additionally MR and PET scans of the 5-HT4 receptor function will be conducted before and after 4 weeks of treatment
Recent studies point at disturbed regulation of the hypothalamic-pituitary-adrenocortical HPA system as a possible endo-phenotype for depression
The hypothesis of AGENDA are that endo-phenotypes are affected by treatment with antidepressants in healthy first degree relatives
AGENDA is a four week randomized placebo-controlled double-blind trial in which first degree relatives of patients with the diagnosis of depression are randomised in to two groups which are treated with either placebo or antidepressant medicine Cipralex We expect to include 80 healthy subjects with the predisposition for depression since one of their parents or siblings recently was treated for depression
The subjects will be examined before and after four weeks of treatment by a thorough interview concerning psychiatric symptoms SCAN including depressive symptoms personality perceived stress and cognitive function The effect of antidepressant on stress is measured with saliva-cortisol and by the response to the combined dexamethasone corticotropin-releasing CRH hormone test Additionally MR and PET scans of the 5-HT4 receptor function will be conducted before and after 4 weeks of treatment
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