Outcome Following Antidepressant Treatment on Possible Endo-Phenotypes for Major Depression
NCT ID: NCT00386841
Last Updated: 2009-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2007-04-30
2009-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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A Escitalopram 10 mg
Escitalopram 10 mg
Escitalopram
Escitalopram 10 mg p.o. per day
Placebo
Placebo
Placebo
Placebo
Interventions
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Escitalopram
Escitalopram 10 mg p.o. per day
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Born in Denmark with European parents and grandparents
* For women; not pregnant or breastfeeding
* Written informed consent
Exclusion Criteria
* Daily intake of drugs interfering with corticosteroids or escitalopram
* Hypersensitivity to escitalopram, dexamethasone or human corticotropin-releasing hormone
* Former medical or psychological treatment for diseases in the affective or schizophrenic spectrum
* Ongoing addiction of alcohol or psychoactive drugs
18 Years
60 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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University of Copenhagen
Principal Investigators
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Lars V Kessing, DMSc
Role: STUDY_DIRECTOR
Psychiatric Department of Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen OE
Locations
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Psychiatric Department of Rigshospitalet
Blegdamsvej 9, Copenhagen OE, Denmark
Countries
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References
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Knorr U, Vinberg M, Mortensen EL, Winkel P, Gluud C, Wetterslev J, Gether U, Kessing LV. Effect of chronic escitalopram versus placebo on personality traits in healthy first-degree relatives of patients with depression: a randomized trial. PLoS One. 2012;7(2):e31980. doi: 10.1371/journal.pone.0031980. Epub 2012 Feb 29.
Knorr U, Vinberg M, Hansen A, Klose M, Feldt-Rasmussen U, Hilsted L, Hasselstrom J, Gether U, Winkel P, Gluud C, Wetterslev J, Kessing LV. Escitalopram and neuroendocrine response in healthy first-degree relatives to depressed patients--a randomized placebo-controlled trial. PLoS One. 2011;6(6):e21224. doi: 10.1371/journal.pone.0021224. Epub 2011 Jun 27.
Knorr U, Vinberg M, Klose M, Feldt-Rasmussen U, Hilsted L, Gade A, Haastrup E, Paulson O, Wetterslev J, Gluud C, Gether U, Kessing L. Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: the effect of escitalopram versus placebo on the combined dexamethasone-corticotrophine releasing hormone test and other potential endophenotypes in healthy first-degree relatives of persons with depression. Trials. 2009 Aug 11;10:66. doi: 10.1186/1745-6215-10-66.
Other Identifiers
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AGENDA
Identifier Type: -
Identifier Source: org_study_id