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Completed

NCT Number: NCT00308893

BDNF Gene Polymorphism and Antidepressants Treatment

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CPU CHRU de Tours

Tours, 37044, France

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic analysis

Genetic

Compare BDNF polymorphism among responders and non-responders

Primary outcomes

  1. Score on Montgomery and Asberg Depression Rating Scale (MADRS)

    Time frame: At 3 weeks and 6 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Mar 30, 2006
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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