Outcome Following Antidepressant Treatment on Possible Endo-Phenotypes for Major Depression
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Associations Between Gene-Polymorphisms, Endo-Phenotypes for Depression and Antidepressive Treatment (AGENDA)|
- Changes in the response on the combined dexamethasone corticotropin-releasing hormone test before and after 4 weeks treatment with escitalopram or placebo. [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
- Changes in scores before and after 4 weeks treatment with escitalopram or placebo on: Cognition [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
- Social function [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
- Neuroticism [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
- Subjective; sleep, pain, aggression, depression, anxiety, quality of life, perceived stress and side-effects [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
- Receptor status by PET-scans [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
- Inflammatory parameters [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
- Paraclinical measures [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
- MR and fMRI [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: A Escitalopram 10 mg
Escitalopram 10 mg
Escitalopram 10 mg p.o. per day
Other Name: cipralex
Placebo Comparator: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386841
|Psychiatric Department of Rigshospitalet|
|Blegdamsvej 9, Copenhagen OE, Denmark, 2100|
|Study Director:||Lars V Kessing, DMSc||Psychiatric Department of Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen OE|