DepressionPhase 4NCT00308893
BDNF Gene Polymorphism and Antidepressants Treatment
A Phase 4 study testing Genetic analysis in people with Depression, run by University Hospital, Tours at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Genetic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2006to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Derived Neurotrophic Factor (BDNF) Gene Polymorphism and Response to Antidepressants Treatment in Major Depression
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Genetic analysis
- Keywords
- Antidepressants, escitalopram, Genetic polymorphism
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysisGenetic
Compare BDNF polymorphism among responders and non-responders
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Treatment response after 3 and 6 weeks Receives: Genetic: Genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Montgomery and Asberg Depression Rating Scale (MADRS)
Measured: At 3 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
- Investigators
- Wissam EL HAGE, MD, PhD, Principal investigator, UNIVERSITY HOSPITAL OF TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308893
- Sponsor's protocol ID
- AOHP05-WEH/BDNF
- Status last verified
- Dec 2025
- First submitted
- 28 Mar 2006
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25074447
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Derived Neurotrophic Factor (BDNF) Gene Polymorphism and Response to Antidepressants Treatment in Major Depression
- ClinicalTrials.gov ID
- NCT00308893
- Acronym / sponsor ID
- AOHP05-WEH/BDNF
- Conditions
- Depression
- Keywords
- Antidepressants, escitalopram, Genetic polymorphism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Jul 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Genetic: Genetic analysisTreatment response after 3 and 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic analysisCompare BDNF polymorphism among responders and non-responders | Genetic | Escitalopram |
Primary outcome
Score on Montgomery and Asberg Depression Rating Scale (MADRS)
Time frame: At 3 weeks and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 25074447El-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.
Related trials for Depression
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Recruiting
To Improve Depressive Symptoms Using a Web-App
Depression
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wissam EL HAGE, MD, PhD principal investigator
UNIVERSITY HOSPITAL OF TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Genetic analysis in people with Depression, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Montgomery and Asberg Depression Rating Scale (MADRS) (time frame: At 3 weeks and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.