BDNF Gene Polymorphism and Antidepressants Treatment

Condition(s) targeted: Depression

Intervention: escitalopram (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Tours

Official(s) and/or principal investigator(s):
Wissam EL HAGE, MD, PhD, Principal Investigator, Affiliation: UNIVERSITY HOSPITAL OF TOURS

Overall contact:
Wissam EL HAGE, MD, PhD, Phone: +33613218116, Email: el-hage@med.univ-tours.fr

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.

Official title: Brain Derived Neurotrophic Factor (BDNF) Gene Polymorphism and Response to Antidepressants Treatment in Major Depression

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study

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

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

CPU CHRU de Tours, TOURS 37044, France; Recruiting
El HAGE Wissam, Pr, Phone: (33) 2 47 47 80 43, Email: el-hage@med.univ-tours.fr
RAMEAU Pascaline, ARC, Phone: (33) 2 47 36 62 49, Email: rameau@med.univ-tours.fr
El HAGE Wissam, Pr, Principal Investigator
COUTURIER Clémence, Sub-Investigator
BAUDRY Marion, Sub-Investigator
CAMUS Vincent, Sub-Investigator

Starting date: July 2006
Ending date: July 2008
Last updated: May 25, 2007