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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386841
First Posted: October 12, 2006
Last Update Posted: June 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Copenhagen
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • Changes in scores before and after 4 weeks treatment with escitalopram or placebo on: Cognition [ Time Frame: 4-6 weeks ]
  • Social function [ Time Frame: 4-6 weeks ]
  • Neuroticism [ Time Frame: 4-6 weeks ]
  • Subjective; sleep, pain, aggression, depression, anxiety, quality of life, perceived stress and side-effects [ Time Frame: 4-6 weeks ]
  • Receptor status by PET-scans [ Time Frame: 4-6 weeks ]
  • Inflammatory parameters [ Time Frame: 4-6 weeks ]
  • Paraclinical measures [ Time Frame: 4-6 weeks ]
  • MR and fMRI [ Time Frame: 4-6 weeks ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 11, 2006
First Posted: October 12, 2006
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by University of Copenhagen:
Major depression
First degree relatives
Escitalopram
Cortisol
Cognition
Personality
Endo-phenotype

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents