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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386841
• Other study ID #: AGENDA
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2006
• Last updated: June 29, 2009
• Start date: April 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Escitalopram
Escitalopram 10 mg p.o. per day
• Placebo
Placebo

Locations

Country	Name	City	State
Denmark	Psychiatric Department of Rigshospitalet	Blegdamsvej 9	Copenhagen OE

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in scores before and after 4 weeks treatment with escitalopram or placebo on: Cognition		4-6 weeks	No
Secondary	Social function		4-6 weeks	No
Secondary	Neuroticism		4-6 weeks	No
Secondary	Subjective; sleep, pain, aggression, depression, anxiety, quality of life, perceived stress and side-effects		4-6 weeks	No
Secondary	Receptor status by PET-scans		4-6 weeks	No
Secondary	Inflammatory parameters		4-6 weeks	No
Secondary	Paraclinical measures		4-6 weeks	No
Secondary	MR and fMRI		4-6 weeks	No