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BDNF Gene Polymorphism and Antidepressants Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Tours.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00308893
First received: March 28, 2006
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  Purpose

The main hypothesis is that the therapeutic response and pharmacological resistance to ADs in depressed patients can be associated with a polymorphism for the BDNF gene. The research of allelic forms associated to lesser efficiency or inefficiency of ADs could add to the body of evidence that BDNF mediates the mechanism of action of ADs, and could have important practical implications. We propose to compare in a group of patients with major depression, the allelic variability of the BDNF gene between responders and non-responders after a 3-week period and a 6-week period of SSRI treatment.


Condition Intervention Phase
Depression
 Drug: escitalopram
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brain Derived Neurotrophic Factor (BDNF) Gene Polymorphism and Response to Antidepressants Treatment in Major Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Score on a depression rating scale at 3 weeks and 6 weeks using the Montgomery and Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures:
  • A clinical check-up comprises a measure of arterial tension, of cardiac pulse, of weight and height allowing to calculate the Body Mass Index
  • A biological check-up comprises a blood ionogram, a hemogram, a glycaemia, a dosage of triglycerides and cholesterol
  • A research of the BDNF polymorphism

Estimated Enrollment: 200
Study Start Date: July 2006
Estimated Study Completion Date: March 2012
Detailed Description:
  • The main objective is to research an association between polymorphism for the BDNF gene and the 3-week and 6-week response to a SSRI treatment (escitalopram) in major depression.
  • A case control pilot study without any direct individual benefit (200 patients).
  • Study period: 24 months.
  • Scores from reliable and validated psychometric scales (Montgomery and Asberg Depression Scale, Mini International Neuropsychiatric Interview) specifically analysing depression dimension at the time of inclusion, after three and six weeks of antidepressant treatment.
  • Genetic analysis researching a polymorphism of the BDNF gene is done by a blood sample at the baseline.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient suffering a severe depressive episode (according to DSM-IV), evolving since at least 2 weeks before entering the study
  • Age superior to 18 years
  • Caucasian type
  • In absence of any medicinal treatment that could enhance depression: methyldopa, beta-blockers, reserpine,
  • In absence of hypothyroidia or anaemia
  • Without comorbidity that could affect therapy response : e.g. food disorder, substance abuse or dependence syndrome

Exclusion Criteria:

- Will be excluded from the study the patients for which a modification of the depression diagnosis (according to the DSM-IV criteria) takes place during the period of study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308893

Contacts
Contact: Wissam EL HAGE, MD, PhD +33613218116 el-hage@med.univ-tours.fr

Locations
France
CPU CHRU de Tours Recruiting
Tours, France, 37044
Contact: El HAGE Wissam, Pr     (33) 2 47 47 80 43     el-hage@med.univ-tours.fr    
Contact: LABBE Delphine, ARC     (33) 2 47 47 46 65     labbe@med.univ-tours.fr    
Principal Investigator: El HAGE Wissam, Pr            
Sub-Investigator: COUTURIER Clémence            
Sub-Investigator: BAUDRY Marion            
Sub-Investigator: CAMUS Vincent            
Sponsors and Collaborators
University Hospital, Tours
H. Lundbeck A/S
Investigators
Principal Investigator: Wissam EL HAGE, MD, PhD UNIVERSITY HOSPITAL OF TOURS
  More Information

No publications provided

Responsible Party: University Hospital Tours
ClinicalTrials.gov Identifier: NCT00308893     History of Changes
Other Study ID Numbers: AOHP05-WEH/BDNF
Study First Received: March 28, 2006
Last Updated: March 8, 2011
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by University Hospital, Tours:
Antidepressants
escitalopram
Genetic polymorphism

Additional relevant MeSH terms:
Depression
Depressive Disorder
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 May 19, 2013