NCT00308893

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

5.9 years

First QC Date

March 28, 2006

Last Update Submit

December 16, 2025

Conditions

Keywords

AntidepressantsescitalopramGenetic polymorphism

Outcome Measures

Primary Outcomes (1)

  • Score on Montgomery and Asberg Depression Rating Scale (MADRS)

    At 3 weeks and 6 weeks

Study Arms (1)

Escitalopram

EXPERIMENTAL

Treatment response after 3 and 6 weeks

Genetic: Genetic analysis

Interventions

Compare BDNF polymorphism among responders and non-responders

Escitalopram

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPU CHRU de Tours

Tours, 37044, France

Location

Related Publications (1)

  • El-Hage W, Vourc'h P, Gaillard P, Leger J, Belzung C, Ibarguen-Vargas Y, Andres CR, Camus V. The BDNF Val(66)Met polymorphism is associated with escitalopram response in depressed patients. Psychopharmacology (Berl). 2015 Feb;232(3):575-81. doi: 10.1007/s00213-014-3694-z. Epub 2014 Jul 31.

MeSH Terms

Conditions

Depression

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Wissam EL HAGE, MD, PhD

    UNIVERSITY HOSPITAL OF TOURS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 30, 2006

Study Start

July 1, 2006

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations