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

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Escitalopram Drug: Placebo	Phase 4

Study Type:	Interventional
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)

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	80
Study Start Date:	April 2007
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Escitalopram 10 mg Escitalopram 10 mg	Drug: Escitalopram Escitalopram 10 mg p.o. per day Other Name: cipralex
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo Other Name: Placebo

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386841

Locations

Denmark
Psychiatric Department of Rigshospitalet
Blegdamsvej 9, Copenhagen OE, Denmark, 2100

Sponsors and Collaborators

University of Copenhagen

Investigators

Study Director:

Lars V Kessing, DMSc

Psychiatric Department of Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen OE

More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2012 Feb 29.

Knorr U, Vinberg M, Hansen A, Klose M, Feldt-Rasmussen U, Hilsted L, Hasselstrøm 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. 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.

Responsible Party:	Lars Vedel Kessing and Ulrik Gether, professors, University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00386841 History of Changes
Other Study ID Numbers:	AGENDA
Study First Received:	October 11, 2006
Last Updated:	June 29, 2009
Health Authority:	Denmark: Danish Medicines Agency Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency

Keywords provided by University of Copenhagen:

Major depression
First degree relatives
Escitalopram
Cortisol

Cognition
Personality
Endo-phenotype

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents

Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on June 18, 2013