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BDNF Gene Polymorphism and Antidepressants Treatment

NCT ID: NCT00308893

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Depression

Keywords

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Antidepressants escitalopram Genetic polymorphism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Escitalopram

Treatment response after 3 and 6 weeks

Group Type EXPERIMENTAL

Genetic analysis

Intervention Type GENETIC

Compare BDNF polymorphism among responders and non-responders

Interventions

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Genetic analysis

Compare BDNF polymorphism among responders and non-responders

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wissam EL HAGE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UNIVERSITY HOSPITAL OF TOURS

Locations

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CPU CHRU de Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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AOHP05-WEH/BDNF

Identifier Type: -

Identifier Source: org_study_id