Associations Between Gene-Polymorphisms, Endo-Phenotypes for Depression and Antidepressive Treatment (AGENDA)
Overview
- Phase
- Phase 4
- Intervention
- Escitalopram
- Conditions
- Healthy
- Sponsor
- University of Copenhagen
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes in the response on the combined dexamethasone corticotropin-releasing hormone test before and after 4 weeks treatment with escitalopram or placebo.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Offsprings or siblings of patients with major depression
- •Born in Denmark with European parents and grandparents
- •For women; not pregnant or breastfeeding
- •Written informed consent
Exclusion Criteria
- •Somatically illness or other handicaps which make participation in the study impossible
- •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
Arms & Interventions
A Escitalopram 10 mg
Escitalopram 10 mg
Intervention: Escitalopram
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Changes in scores before and after 4 weeks treatment with escitalopram or placebo on: Cognition(4-6 weeks)
- Social function(4-6 weeks)
- Neuroticism(4-6 weeks)
- Subjective; sleep, pain, aggression, depression, anxiety, quality of life, perceived stress and side-effects(4-6 weeks)
- Receptor status by PET-scans(4-6 weeks)
- Inflammatory parameters(4-6 weeks)
- Paraclinical measures(4-6 weeks)
- MR and fMRI(4-6 weeks)