Major Depressive DisorderPhase 4DEPARRESTCLINNCT02051413
Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder (MDD) (DEPARRESTCLIN)
A Phase 4 study testing Venlafaxine extended release in people with Major Depressive Disorder and Major Depressive Episode, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Predictive factors and biomarkers of response to antidepressants in major depressive disorder are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and desensitize serotonergic and dopaminergic receptors. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Major Depressive Episode
- What is being tested?
- Venlafaxine extended release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2014to May 2018
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Major Depressive Disorder
- current Major Depressive Episode
- Hamilton Depression Rating Scale score > 18
- requiring a new treatment with venlafaxine
- written informed consent
Who cannot join
- bipolar disorder
- psychotic disorder
- unstable somatic condition
- contraindication to cerebral RMI
- current treatment with mood stabilizers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder
Predictive factors and biomarkers of response to antidepressants in major depressive disorder are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and desensitize serotonergic and dopaminergic receptors. The study hypothesis is that Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants in major depressive disorder. In a controlled prospective open naturalistic monocentric 3-month study, 60 patients with a major depressive disorder requiring a treatment with venlafaxine will be included and assessed before treatment, 1 month and 3 months post-treatment. 20 controlled healthy subjects matched for age and gender will also be assessed. The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral Blood Mononuclear Cell measures and functional pathway. Antidepressant response will be assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.
Read the detailed description
Rationale: Predictive factors and biomarkers of response to antidepressants in major depressive disorder are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and desensitize serotonergic and dopaminergic receptors.
Hypothesis: The study hypothesis is that Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants in major depressive disorder.
Method: In a controlled prospective open naturalistic monocentric 3-month study, 60 patients with a major depressive disorder requiring a treatment with venlafaxine will be included and assessed before treatment, 1 month and 3 months post-treatment. 20 controlled healthy subjects matched for age and gender will also be assessed.
Assessments:
The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral Blood Mononuclear Cell measures and functional pathway.
Antidepressant response will be assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.
- Being tested
- Venlafaxine extended release
- Keywords
- Major depression, Antidepressant drug, Beta-arrestin, Biomarker, Predictive factor
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venlafaxine extended releaseDrug
Also called EFFEXOR
antidepressant drug
| Study group | Role | What they receive |
|---|---|---|
| Venlafaxine extended release | Other | Venlafaxine extended-release, flexible dose Receives: Drug: Venlafaxine extended release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study start18 Feb 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- 67 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Corruble, MD, PhD, Principal investigator, Inserm U669, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051413
- Sponsor's protocol ID
- C13-25
- Other IDs
- 2013-004326-29
- Acronym
- DEPARRESTCLIN
- Status last verified
- Aug 2021
- First submitted
- 22 Jan 2014
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Colle R, El Asmar K, Verstuyft C, Lledo PM, Lazarini F, Chappell K, Deflesselle E, Ait Tayeb AEK, Falissard B, Duron E, Rotenberg S, Costemale-Lacoste JF, David DJ, Gressier F, Gardier AM, Hummel T, Becquemont L, Corruble E. The olfactory deficits of depressed patients are restored after remission with venlafaxine treatment. Psychol Med. 2022 Aug;52(11):2062-2070. doi: 10.1017/S0033291720003918. Epub 2020 Oct 22.
PubMed 33087184Baudouin E, Corruble E, Gori P, Bloch I, Becquemont L, Duron E, Colle R. White matter hyperintensities and their role in major depressive episodes: a cross-sectional study in adults under 65. Braz J Psychiatry. 2025;47:e20243921. doi: 10.47626/1516-4446-2024-3921. Epub 2024 Dec 28.
PubMed 39731725Mesdom P, Colle R, Becquemont L, Chappell K, David DJ, Mendez-David I, Corruble E, Verstuyft C. Tobacco use is associated with low peripheral beta-arrestin 1 levels in major depression: A preliminary report. Drug Alcohol Depend. 2022 Nov 1;240:109653. doi: 10.1016/j.drugalcdep.2022.109653. Epub 2022 Oct 2.
PubMed 36209675Etienne J, Boutigny A, David DJ, Deflesselle E, Gressier F, Becquemont L, Corruble E, Colle R. Habenular volume changes after venlafaxine treatment in patients with major depression. Psychiatry Clin Neurosci. 2024 Aug;78(8):468-472. doi: 10.1111/pcn.13684. Epub 2024 Jun 12.
PubMed 38867362Cussotto S, Colle R, Voican CS, Ciocan DM, Trainel N, Bottemanne H, Pelloux Y, David DJ, Cassard AM, Perlemuter G, Corruble E. The Gut Microbiota Is Altered in Antidepressant-Free Depressed Patients and Is Associated With Depression Severity. J Neurochem. 2025 Jul;169(7):e70173. doi: 10.1111/jnc.70173.
PubMed 40717539
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02051413
- Acronym / sponsor ID
- DEPARRESTCLIN / C13-25
- Keywords
- Major depression, Antidepressant drug, Beta-arrestin, Biomarker, Predictive factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 18 Feb 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 31 Jan 2014 (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.
Predictive factors and biomarkers of response to antidepressants in major depressive disorder are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and desensitize serotonergic and dopaminergic receptors. The study hypothesis is that Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants in major depressive disorder. In a controlled prospective open naturalistic monocentric 3-month study, 60 patients with a major depressive disorder requiring a treatment with venlafaxine will be included and assessed before treatment, 1 month and 3 months post-treatment. 20 controlled healthy subjects matched for age and gender will also be assessed. The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral Blood Mononuclear Cell measures and functional pathway. Antidepressant response will be assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.
Detailed description
Rationale: Predictive factors and biomarkers of response to antidepressants in major depressive disorder are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and desensitize serotonergic and dopaminergic receptors.
Hypothesis: The study hypothesis is that Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants in major depressive disorder.
Method: In a controlled prospective open naturalistic monocentric 3-month study, 60 patients with a major depressive disorder requiring a treatment with venlafaxine will be included and assessed before treatment, 1 month and 3 months post-treatment. 20 controlled healthy subjects matched for age and gender will also be assessed.
Assessments:
The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral Blood Mononuclear Cell measures and functional pathway.
Antidepressant response will be assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine extended release | Other | Drug: Venlafaxine extended releaseVenlafaxine extended-release, flexible dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major Depressive Disorder
- current Major Depressive Episode
- Hamilton Depression Rating Scale score > 18
- requiring a new treatment with venlafaxine
- written informed consent
Key exclusion criteria (5 listed)
- bipolar disorder
- psychotic disorder
- unstable somatic condition
- contraindication to cerebral RMI
- current treatment with mood stabilizers
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 |
|---|---|---|
| Venlafaxine extended releaseAlso: EFFEXORantidepressant drug | Drug | Venlafaxine extended release |
Primary outcome
Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items
Time frame: 3 months
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 2 Sep 2025.
- Results publication: PubMed 33087184Colle R, El Asmar K, Verstuyft C, Lledo PM, Lazarini F, Chappell K, Deflesselle E, Ait Tayeb AEK, Falissard B, Duron E, Rotenberg S, Costemale-Lacoste JF, David DJ, Gressier F, Gardier AM, Hummel T, Becquemont L, Corruble E. The olfactory deficits of depressed patients are restored after remission with venlafaxine treatment. Psychol Med. 2022 Aug;52(11):2062-2070. doi: 10.1017/S0033291720003918. Epub 2020 Oct 22.
- Results publication: PubMed 39731725Baudouin E, Corruble E, Gori P, Bloch I, Becquemont L, Duron E, Colle R. White matter hyperintensities and their role in major depressive episodes: a cross-sectional study in adults under 65. Braz J Psychiatry. 2025;47:e20243921. doi: 10.47626/1516-4446-2024-3921. Epub 2024 Dec 28.
- Results publication: PubMed 36209675Mesdom P, Colle R, Becquemont L, Chappell K, David DJ, Mendez-David I, Corruble E, Verstuyft C. Tobacco use is associated with low peripheral beta-arrestin 1 levels in major depression: A preliminary report. Drug Alcohol Depend. 2022 Nov 1;240:109653. doi: 10.1016/j.drugalcdep.2022.109653. Epub 2022 Oct 2.
- Results publication: PubMed 38867362Etienne J, Boutigny A, David DJ, Deflesselle E, Gressier F, Becquemont L, Corruble E, Colle R. Habenular volume changes after venlafaxine treatment in patients with major depression. Psychiatry Clin Neurosci. 2024 Aug;78(8):468-472. doi: 10.1111/pcn.13684. Epub 2024 Jun 12.
- Results publication: PubMed 40717539Cussotto S, Colle R, Voican CS, Ciocan DM, Trainel N, Bottemanne H, Pelloux Y, David DJ, Cassard AM, Perlemuter G, Corruble E. The Gut Microbiota Is Altered in Antidepressant-Free Depressed Patients and Is Associated With Depression Severity. J Neurochem. 2025 Jul;169(7):e70173. doi: 10.1111/jnc.70173.
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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.
Emmanuelle Corruble, MD, PhD principal investigator
Inserm U669, APHP
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 Venlafaxine extended release in people with Major Depressive Disorder and Major Depressive Episode, run by Institut National de la Santé Et de la Recherche Médicale, France 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 5 inclusion and 5 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 2 Sep 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?
Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items (time frame: 3 months). 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 NCT02051413, which also lists 5 linked publications.
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 2 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.