Depression, BipolarANTaRESNCT05568823
Biomarkers of ANTidepressant RESponse and Development Risk of Bipolar Disorder
A study testing Blood sampling in people with Depression, Bipolar and Major Depressive Disorder, run by Assistance Publique Hopitaux De Marseille.
Trial summary
One in five people will present a major depressive episode (MDE) in their lifetime. While antidepressants (ADs) are currently the standard treatment for MDE, the first AD prescribed is effective in less than 40% of patients and a complete clinical response is only observed after several weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Bipolar, Major Depressive Disorder, Bipolar Disorder
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 2 Jan 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient between 18 and 65 years of age
- Sufficient knowledge of the French language to complete the assessments
- Inpatients or outpatients with a major depressive episode (DSM-5 criteria);
- Score above 19 on the MADRS depression scale (moderate to severe depression);
- Without antidepressants, mood stabilizers or antipsychotics treatment or having stopped the previous medication(s) for more than 5 times the half-life of the prescribed treatment(s);
- Eligible for antidepressant monotherapy with SERTRALINE or FLUOXETINE or DULOXETINE or MAPROTILINE, with or without benzodiazepine therapy, and in whom treatment is feasible within days of inclusion.
Who cannot join
- • Patient with bipolar disorder, schizophrenia or psychotic disorder as defined by the DSM-5 and assessed by the MINI or any other pathology or treatment deemed clinically incompatible with the study by the investigator;
- Patient with moderate to severe substance use disorders (>=4/11 criteria as defined in the DSM-5) and with the exception of smoking disorders
- Patient with pregnancy, unstable physiological condition or severe and symptomatic medical condition;
- Patient with a diagnosed neurological disorder affecting central nervous system function;
- Patient unable to give informed consent to participate in this study or unable to give the volunteer informed information;
- Patient who are not covered by a social security system;
- Patient under court protection or guardianship
- Patient who have received a vaccination within one month prior to initiation of treatment or who plan to be vaccinated within 2 weeks of initiation of treatment > For patient undergoing MRI: presence of a contraindication for MRI examination.
Trial locations and contacts
No sites are listed yet.
About this study
One in five people will present a major depressive episode (MDE) in their lifetime. While antidepressants (ADs) are currently the standard treatment for MDE, the first AD prescribed is effective in less than 40% of patients and a complete clinical response is only observed after several weeks. Identifying early biomarkers of the response to treatment with an AD could allow the clinician to rapidly identify patients in whom treatment will not be effective and therefore modify patient care. We have recently shown that the messenger RNA (mRNA) of two proteins, ELK1 and GPR56, were present in different amounts in the blood cells of "responder" compared to those of "non-respondent" patients. In this context, our main objective will be to determine whether ELK1 and GPR56 mRNAs, are very early biomarkers of the response to AD, i.e., biomarkers whose variation precedes the clinical response by several weeks. Secondary objectives will be to identify early phase changes in neurophysiological measures, cognitive and behavioral tasks, as well as levels of blood coding and non-coding RNAs, serum cytokine, mitochondrial and metabolic markers, neuroimaging markers as biomarkers of differential treatment outcomes to antidepressant treatment.
Patients will be treated with SERTRALINE or FLUOXETINE or DULOXETINE or MAPROTILINE (in monotherapy) with or without adjunct benzodiazepine.
Read more
Patients are identified as responders or non-responders based on their clinical assessment at 8 weeks after treatment onset.
In addition, a second stage will collect data to address another important issue for the management of patients with a MDE: to discriminate those with a major depressive disorder (MDD) from those with a bipolar disorder (BD). BD diagnosis is one of the most common reasons of failure to response to ADs. Therefore, one of our secondary objectives will be to identify biomarkers to differentiate between these two categories of patients. To do this, we will follow patients for a period of 24 months to identify those who will present during this follow-up the diagnostic criteria of bipolarity.
- Being tested
- Blood sampling
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Also called Psychiatric survey, MRI Exam
Measurement of markers of disease evolution
| Study group | Role | What they receive |
|---|---|---|
| Patients "responding" to treatment after 8 weeks of treatment | Other | Patients "responding" to treatment after 8 weeks of treatment: i.e. whose clinical evolution is beneficial. Receives: Other: Blood sampling |
| Patients "non-responding" to treatment after 8 weeks of treatment | Other | Patients "non-responding" to treatment after 8 weeks of treatment: i.e. whose clinical evolution is not satisfactory. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value for antidepressant response of ELK1 mRNA levels or changes 3 days after AD start
The area under the curve (AUC) value determined by receiving operating characteristic (ROC) analysis of ELK1 mRNA levels for the evolution of psychiatric symptoms following AD start, during a 8-weeks follow-up. Patients are identified as responders or nonresponders based on their clinical assessment
Measured: 8 weeks of treatment
Secondary outcomes (5)
Predictive value for antidepressant response of GPR56 and ELK1 mRNA levels at baseline, 3 days, 2 weeks or 8 weeks after AD start
The area under the curve (AUC) value determined by receiving operating characteristic (ROC) analysis of GPR56 and ELK1 ELISA tests from whole blood for the evolution of psychiatric symptoms following AD start, during a 8-weeks follow-up. Patients are identified as responders or nonresponders based on their clinical assessment
Measured: 8 weeks of treatment
Predictive value for antidepressant response of coding and non-coding (micro, circular, long non coding) RNA blood levels at baseline, 3 days, 2 weeks or 8 weeks after AD start
The area under the curve (AUC) value determined by receiving operating characteristic (ROC) analysis of coding and non-coding (micro, circular, long non coding) blood RNA levels for the evolution of psychiatric symptoms following AD start, during a 8-weeks follow-up. Patients are identified as responders or nonresponders based on their clinical assessment
Measured: 8 weeks of treatment
Predictive value for antidepressant response of serum cytokine concentration measured by immunoassay at baseline, 3 days, 2 weeks or 8 weeks, after AD start
The area under the curve (AUC) value determined by receiving operating characteristic (ROC) analysis of serum cytokine concentration measured by immunoassay for the evolution of psychiatric symptoms following AD start, during a 8-weeks follow-up. Patients are identified as responders or nonresponders based on their clinical assessment
Measured: 8 weeks of treatment
Predictive value for antidepressant response of peripheral mitochondrial markers at baseline, 3 days 2 weeks or 8 weeks, after AD start Time Frame: 8 weeks of treatment
The area under the curve (AUC) value determined by receiving operating characteristic (ROC) analysis of peripheral mitochondrial markers for the evolution of psychiatric symptoms following AD start, during a 8-weeks follow-up. Patients are identified as responders or nonresponders based on their clinical assessment
Measured: 8 weeks of treatment
Predictive value for antidepressant response of MRI features
The area under the curve (AUC) value determined by receiving operating characteristic (ROC) analysis of MRI analysis for the evolution of psychiatric symptoms following AD start, during a 8-weeks follow-up. Patients are identified as responders or nonresponders based on their clinical assessment
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion2 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, BipolarStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Stratification on two groups of patients subsequently identified as responders or non-responders, after 8 weeks of treatment. Patients will be classified as responders or non-responders on the basis of the evolution of the MADRS depression scale score, i.e. an improvement of more than 50% in the intensity of symptoms between the beginning of the treatments and 8 weeks afterwards.
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568823
- Sponsor's protocol ID
- 2020-51
- Acronym
- ANTaRES
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of ANTidepressant RESponse and Development Risk of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05568823
- Acronym / sponsor ID
- ANTaRES / 2020-51
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 2 Jan 2025 (estimated)
- First posted
- 6 Oct 2022 (actual)
- 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.
One in five people will present a major depressive episode (MDE) in their lifetime. While antidepressants (ADs) are currently the standard treatment for MDE, the first AD prescribed is effective in less than 40% of patients and a complete clinical response is only observed after several weeks. Identifying early biomarkers of the response to treatment with an AD could allow the clinician to rapidly identify patients in whom treatment will not be effective and therefore modify patient care. We have recently shown that the messenger RNA (mRNA) of two proteins, ELK1 and GPR56, were present in different amounts in the blood cells of "responder" compared to those of "non-respondent" patients. In this context, our main objective will be to determine whether ELK1 and GPR56 mRNAs, are very early biomarkers of the response to AD, i.e., biomarkers whose variation precedes the clinical response by several weeks. Secondary objectives will be to identify early phase changes in neurophysiological measures, cognitive and behavioral tasks, as well as levels of blood coding and non-coding RNAs, serum cytokine, mitochondrial and metabolic markers, neuroimaging markers as biomarkers of differential treatment outcomes to antidepressant treatment.
Patients will be treated with SERTRALINE or FLUOXETINE or DULOXETINE or MAPROTILINE (in monotherapy) with or without adjunct benzodiazepine.
Patients are identified as responders or non-responders based on their clinical assessment at 8 weeks after treatment onset.
In addition, a second stage will collect data to address another important issue for the management of patients with a MDE: to discriminate those with a major depressive disorder (MDD) from those with a bipolar disorder (BD). BD diagnosis is one of the most common reasons of failure to response to ADs. Therefore, one of our secondary objectives will be to identify biomarkers to differentiate between these two categories of patients. To do this, we will follow patients for a period of 24 months to identify those who will present during this follow-up the diagnostic criteria of bipolarity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stratification on two groups of patients subsequently identified as responders or non-responders, after 8 weeks of treatment. Patients will be classified as responders or non-responders on the basis of the evolution of the MADRS depression scale score, i.e. an improvement of more than 50% in the intensity of symptoms between the beginning of the treatments and 8 weeks afterwards.
| Arm | Type | Receives |
|---|---|---|
| Patients "responding" to treatment after 8 weeks of treatment | Other | Other: Blood samplingPatients "responding" to treatment after 8 weeks of treatment: i.e. whose clinical evolution is beneficial. |
| Patients "non-responding" to treatment after 8 weeks of treatment | Other | Other: Blood samplingPatients "non-responding" to treatment after 8 weeks of treatment: i.e. whose clinical evolution is not satisfactory. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patient between 18 and 65 years of age
- Sufficient knowledge of the French language to complete the assessments
- Inpatients or outpatients with a major depressive episode (DSM-5 criteria);
- Score above 19 on the MADRS depression scale (moderate to severe depression);
- Without antidepressants, mood stabilizers or antipsychotics treatment or having stopped the previous medication(s) for more than 5 times the half-life of the prescribed treatment(s);
Key exclusion criteria (8 listed)
- • Patient with bipolar disorder, schizophrenia or psychotic disorder as defined by the DSM-5 and assessed by the MINI or any other pathology or treatment deemed clinically incompatible with the study by the investigator;
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 |
|---|---|---|
| Blood samplingAlso: Psychiatric survey, MRI ExamMeasurement of markers of disease evolution | Other | Patients "non-responding" to treatment after 8 weeks of treatment, Patients "responding" to treatment after 8 weeks of treatment |
Primary outcome
Predictive value for antidepressant response of ELK1 mRNA levels or changes 3 days after AD start
Time frame: 8 weeks of treatment
The area under the curve (AUC) value determined by receiving operating characteristic (ROC) analysis of ELK1 mRNA levels for the evolution of psychiatric symptoms following AD start, during a 8-weeks follow-up. Patients are identified as responders or nonresponders based on their clinical assessment
5 secondary outcomes
Predictive value for antidepressant response of GPR56 and ELK1 mRNA levels at baseline, 3 days, 2 weeks or 8 weeks after AD start
Time frame: 8 weeks of treatment
Predictive value for antidepressant response of coding and non-coding (micro, circular, long non coding) RNA blood levels at baseline, 3 days, 2 weeks or 8 weeks after AD start
Time frame: 8 weeks of treatment
Predictive value for antidepressant response of serum cytokine concentration measured by immunoassay at baseline, 3 days, 2 weeks or 8 weeks, after AD start
Time frame: 8 weeks of treatment
Predictive value for antidepressant response of peripheral mitochondrial markers at baseline, 3 days 2 weeks or 8 weeks, after AD start Time Frame: 8 weeks of treatment
Time frame: 8 weeks of treatment
Predictive value for antidepressant response of MRI features
Time frame: 8 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Depression, Bipolar
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder
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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Depression, Bipolar and Major Depressive Disorder, run by Assistance Publique Hopitaux De Marseille.
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 8 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: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raoul BELZEAUX, MD (04 91 74 46 46 ext. 33, raoul.belzeaux@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value for antidepressant response of ELK1 mRNA levels or changes 3 days after AD start (time frame: 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2022.