Skip to content

Outcome Following Antidepressant Treatment on Possible Endo-Phenotypes for Major Depression

Associations Between Gene-Polymorphisms, Endo-Phenotypes for Depression and Antidepressive Treatment (AGENDA)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00386841
Enrollment
80
Registered
2006-10-12
Start date
2007-04-30
Completion date
2009-06-30
Last updated
2009-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Major depression, First degree relatives, Escitalopram, Cortisol, Cognition, Personality, Endo-phenotype

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.

Interventions

DRUGEscitalopram

Escitalopram 10 mg p.o. per day

DRUGPlacebo

Placebo

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes in the response on the combined dexamethasone corticotropin-releasing hormone test before and after 4 weeks treatment with escitalopram or placebo.4-6 weeks

Secondary

MeasureTime frame
Social function4-6 weeks
Neuroticism4-6 weeks
Subjective; sleep, pain, aggression, depression, anxiety, quality of life, perceived stress and side-effects4-6 weeks
Changes in scores before and after 4 weeks treatment with escitalopram or placebo on: Cognition4-6 weeks
Inflammatory parameters4-6 weeks
Paraclinical measures4-6 weeks
MR and fMRI4-6 weeks
Receptor status by PET-scans4-6 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026