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

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00386841
First received: October 11, 2006
Last updated: June 29, 2009
Last verified: June 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 July 22, 2014