DepressionPhase 2NCT03870776
RESIST : Administration of MAP4343 in Antidepressant Non-Responders Patients Experiencing a Major Depressive Episode
A Phase 2 study testing MAP4343 in people with Depression, run by Mapreg at 10 sites in France.
Trial summary
The study is a phase II, double-blind, randomized, placebo controlled, parallel, multicentric study in 110 patients with drug resistant depression. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- MAP4343
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 10 sitesFrance
- Study dates
- 1 Jun 2019to 7 Nov 2024
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TRD level from to 2 to 4 inclusive according to the Thase \& Rush classification;
- Patient experiencing a Major Depressive Episode (MDE) according to DSM-5 criteria. MDE can be isolated or recurrent. The diagnosis is based on Mini-International Neuropsychiatric Interview (MINI) test;
- Patient who received a previous antidepressant treatment (AD-Y) in monotherapy with vortioxetine, duloxetine or venlafaxine) at optimized dosages during 6 weeks prior to randomization, associated or not to AD-potentiator (quetiapine), are eligible.
- Hamilton Depression Rating Scale (HDRS) score > 21;
- Clinical Global Impressions scale (CGI) ≥ 4;
- Male or female patient, aged 18 to 80 years inclusive;
Show all 23Show fewer
- Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for the duration of the trial and for 4 months after the last study drug administration; Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months);
- Negative pregnancy test at screening baseline;
- Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive;
- Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis, hormonology). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator;
- Normal ECG recording on a 12-lead ECG at the screening visit:
- 120 < PR < 210 ms
- QRS < 120 ms
- QTcF ≤ 430 ms for male and < 450 ms for female,
- No sign of any trouble of sinusal automatism,
- Or considered NCs by investigators;
- Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position:
- 95 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg,
- 50 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg,
- 50 bpm ≤ HR ≤ 80 bpm,
- Or considered NCs by investigators;
- Signing a written informed consent prior to selection;
- Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
Who cannot join
- MDE with mood congruent or not congruent psychotic characteristics;
- Patient hospitalized following the procedures: Psychiatric care at the request of another person (soins psychiatriques à la demande d'un tiers) or Psychiatric care at the request of the state representative (soins psychiatriques sur décision du représentant de l'Etat);
- Suicidal risk in the last month before randomization (C-SSRS: answer yes to the item 3 and/or answer yes to section suicidal behavior; MINI 5.00; suicidal risk section or item 3 of HDRS ≥ 3);
- History of other psychiatric disorder than DME except global anxiety, social phobia, panic troubles that should be accepted. In particular, patients who experienced a depressive state in bipolar disorder 1 or 2, schizophrenic or schizoaffective disorder should not be included;
- Presence or history of drug hypersensitivity, or certain allergic-prone condition diagnosed that could represent a risk factor for an allergic shock;
- Presence or history of hypersensitivity to vortioxetine, duloxetine, venlafaxine or one of their excipients;
Show all 21Show fewer
- Any history or presence of severe hepatic insufficiency and/or of hepatic disease which could lead to hepatic insufficiency;
- Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the time of study participation;
- Any drug intake during the last month prior to the first administration except treatments for concomitant pathologies which are stable since at least 3 months; Benzodiazepine-type anxiolytics, hydroxyzine chlorhydrate, and add-on treatments are authorized within limits described in Section 5.3; For the previous drug intake, the investigator should consider the time needed to sufficiently eliminate a drug from body system, e.g. 5 half-lives of the drug;
- Subjects who received MAOI in monotherapy right before the selection (as ttX);
- General anesthesia within 3 months before administration;
- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months;
- Positive HBs antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests;
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant, calculated creatinine clearance ≤ 60 mL/min;
- Blood donation (including in the frame of a clinical trial) within 2 months before administration;
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
- Medical history which in the opinion of the investigator would make the patient unsuitable for participation in the study (including, but not limited, to patients with coronary insufficiency, thromboembolism diseases);
- Exclusion period of a previous study;
- No possibility of contact in case of emergency;
- History or presence of drug or alcohol abuse (alcohol consumption > 40 g/day);
- Administrative or legal supervision.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Angers
Angers, 49900
CHU Besançon
Besançon, 25000
Cabinet Médical Ambroise Paré
Élancourt, 78990
CHD Vendée
La Roche-sur-Yon, 85000
Hôpital Fontan 1
Lille, 59000
CHU Nantes
Nantes, 44000
APHP Hôpital La Pitié Salpétrière - Prinicipal investigator center
Paris, 75013
Hôpital Ste Anne
Paris, 75014
CHU Henri Laborit
Poitiers, 86000
CHRU Tours
Tours, 37000
About this study
Official title: Double-blind,Controlled,Randomized Phase 2 Study of Efficacy,Safety,Pharmacokinetics& Pharmacodynamics of Daily Oral Administration of MAP4343 During 6 Weeks in Antidepressant Non-responders Patients Experiencing a Major Depressive Episode
The study is a phase II, double-blind, randomized, placebo controlled, parallel, multicentric study in 110 patients with drug resistant depression.
Read the detailed description
This is a phase II, versus placebo, multicentre, double blind, randomized, parallel study in male or female patients with drug resistant depression.
This study targets the antidepressant non-responders' patients who have already experienced at least 2 antidepressant treatments with no success. It is estimated that about 2/3 of the patients treated with antidepressant drugs do not respond partially or completely to the actual conventional treatments (Selective Serotonin Reuptake Inhibitor and Serotonin and Norepinephrine Reuptake Inhibitor).
110 patients with drug resistant depression episode, aged 18 to 80 will be included in the study. They will be recruited from psychiatric consultations in the centers participating to the study.
- Conditions
- Depression
- Being tested
- MAP4343, Placebo
- Keywords
- Depression, Resistant depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP4343Drug
Daily oral administration of MAP4343
PlaceboDrug
Daily oral administration of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo group A | Placebo comparator | Patients will receive the placebo during 42 days. Receives: Drug: Placebo |
| MAP4343 group B | Experimental | Patients will receive daily dose 1 during 42 days. Receives: Drug: MAP4343 |
| MAP4343 group C | Experimental | Patients will receive daily dose 2 during 42 days. Receives: Drug: MAP4343 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale score evolution between baseline and D43
Assessment of HDRS score with 17 items with sides 0 to 2 or 0 to 4. The scores from 0 to 4 correspond respectively to symptoms: absent, doubtful or insignificant, light, moderate, important, those ranging from 0 to 2 to symptoms: absent, doubtful or slight, overt or severe. The total score consists of the addition of the individual scores.
Measured: 43 days
Secondary outcomes (61)
Efficacy of treatment assessed by psychopathological evaluations with Hamilton Depression Rating Scale
psychopathological evaluations at each study visit: Hamilton Depression Rating Scale (17 items with sides 0 to 2 or 0 to 4. The scores from 0 to 4 correspond respectively to symptoms: absent, doubtful or insignificant, light, moderate, important, those ranging from 0 to 2 to symptoms: absent, doubtful or slight, overt or severe. The total score consists of the addition of the individual scores)
Measured: 43 days
Efficacy of treatment assessed by psychopathological evaluations with Montgomery and Asberg Depression rating Scale
psychopathological evaluations at each study visit:Montgomery and Asberg Depression rating Scale used to quatify the intensity of depressive symptomatology
Measured: 43 days
Efficacy of treatment assessed by psychopathological evaluations with Brief Anxiety Scale
psychopathological evaluations at each study visit: Brief Anxiety Scale, a dimensional measure of generalized anxiety with 8 items
Measured: 43 days
Efficacy of treatment assessed by psychopathological evaluations with Scale of Global Clinical Impressions
psychopathological evaluations at each study visit: Scale of Global Clinical Impressions which includes 2 items rated from 1 to 7 (first item is a measurement of the overall measurement of patient's condition; 2nd item evaluates the overall improvementof patient compared to his condition at the admission to the research
Measured: 43 days
Efficacy of treatment assessed by psychopathological evaluations with Quick Inventory of Depressive Symptoms
psychopathological evaluations at each study visit: Quick Inventory of Depressive Symptoms is a questionnaire allowing the assessment of the degree of depression by the patient himself.
Measured: 43 days
Efficacy of treatment assessed by psychopathological evaluations with General Assessment Functioning
psychopathological evaluations at each study visit: General Assessment Functioning. The score is ranged on a hypothetical continuum from 1, the value representing the sickest individual, to 90, a value representing an individual without or with very minimal symptoms and functioning satisfactorily in his social environment or his family. The scale is divided into 9 equal intervals ranging from 1 to 10, 11 to 20, 21 to 30, etc.
Measured: 43 days
Pharmacokinetic assessments with observed maximum plasma concentration (Cmax);
Cmax for MAP4343 in plasma at each study visit.
Measured: 127 days
Pharmacokinetic assessments with first time to reach Cmax (tmax);
tmax for MAP4343 in plasma at each study visit.
Measured: 127 days
Pharmacokinetic assessments with elimination rate constant (Kel);
Kel for MAP4343 in plasma at each study visit.
Measured: 127 days
Pharmacokinetic assessments with plasma elimination half-life (t1/2);
t1/2 for MAP4343 in plasma at each study visit
Measured: 127 days
Pharmacokinetic assessments with plasma area under the plasma concentration-time curve from administration up to infinity with extrapolation of the terminal phase (AUCinf);
AUCinf for MAP4343 in plasma at each study visit
Measured: 127 days
Pharmacokinetic assessments with percentage of extrapolated AUCinf (%AUCextra);
%AUCextra for MAP4343 in plasma at each study visit
Measured: 127 days
Pharmacokinetic assessments with volumn of distribution (Vd/F);
Vd/F for MAP4343 in plasma at each study visit.
Measured: 127 days
Pharmacokinetic assessments with Clearance (Cl/F);
Cl/F for MAP4343 in plasma at each study visit
Measured: 127 days
Pharmacokinetic assessments with accumulation ratio (R);
R for MAP4343 in plasma at each study visit.
Measured: 127 days
Safety parameters assessed by the number of adverse events (AE)
AE evaluation
Measured: 127 days
Safety parameters assessed - Heart rate
Vital signs assessed by heart rate measurement (beats per minute)
Measured: 127 days
Safety parameters assessed by blood pressure
Vital signs assessed by systolic and diastolic blood pressure measurement (mmHg)
Measured: 127 days
Safety parameters assessed - 12-lead Electrocardiogramm
Heart Rate; Electrocardiogramm measure during 12 hours (12-lead ECG) : heart rate (beats per minute)
Measured: 127 days
Safety parameters assessed - 12-lead ElectrocardiogrammPR;
Electrocardiogramm measure during 12 hours (12-lead ECG) : PR interval (milliseconds)
Measured: 127 days
Safety parameters assessed -12-lead Electrocardiogramm : QT
Electrocardiogramm measure during 12 hours (12-lead ECG) : QT interval (milliseconds)
Measured: 127 days
Safety parameters assessed - 12-lead Electrocardiogramm : QTc
Electrocardiogramm measure during 12 hours (12-lead ECG) : QTc with automatic correction (milliseconds)
Measured: 127 days
Safety parameters assessed by hematology parameters : Haemoglobin
Laboratory exams : hematology parameters (Haemoglobin in g/L)
Measured: 127 days
Safety parameters assessed by hematology parameters: Haematocrit
Laboratory exams : hematology parameters (Haematocrit in %)
Measured: 127 days
Safety parameters assessed by hematology parameters: Red blood cells
Laboratory exams : hematology parameters (Red blood cells in Tera/L)
Measured: 127 days
Safety parameters assessed by hematology parameters: White blood cells
Laboratory exams : hematology parameters (White blood cells in Giga/L)
Measured: 127 days
Safety parameters assessed by hematology parameters:Neutrophils
Laboratory exams : hematology parameters (Neutrophils in Giga/L
Measured: 127 days
Safety parameters assessed by hematology parameters: Eosinophils
Laboratory exams : hematology parameters (Eosinophils in Giga/L)
Measured: 127 days
Safety parameters assessed by hematology parameters: Basophils
Laboratory exams : hematology parameters (Basophils in Giga/L)
Measured: 127 days
Safety parameters assessed by hematology parameters: Lymphocytes
Laboratory exams : hematology parameters (Lymphocytes in Giga/L)
Measured: 127 days
Safety parameters assessed by hematology parameters: Monocytes
Laboratory exams : hematology parameters (Monocytes in Giga/L)
Measured: 127 days
Safety parameters assessed by hematology parameters: Platelets
Laboratory exams : hematology parameters (Platelets in Giga/L)
Measured: 127 days
Safety parameters assessed by hematology parameters: Reticulocytes;
Laboratory exams : hematology parameters (Reticulocytes in Giga/L)
Measured: 127 days
Safety parameters assessed by red blood cells indices
MCV; Red blood cells indices : MCV (in picograms)
MCH; Red blood cells indices : MCH (in picograms)
MCHC; Red blood cells indices : MCHC (in picograms)
Measured: 127 days
Safety parameters assessed by hemostasis parameters
INR measurement; Laboratory exams : hemostasis parameters (INR)
Prothrombin time; Laboratory exams : hemostasis parameters (Prothrombin time in seconds)
APTT; Laboratory exams : hemostasis parameters (APTT in seconds)
APTT reference; Laboratory exams : hemostasis parameters (APTT reference in seconds)
Measured: 127 days
Safety parameters assessed by serology parameters
P24 antigen; Laboratory exams : serology (P24 antigen detection)
HIV; Laboratory exams : serology (HIV 1/2 antibodies detection)
HCV; Laboratory exams : serology (HCV antibodies detection)
HBs; Laboratory exams : serology (HBs antigen detection)
Measured: 127 days
Safety parameters assessed by biochemistry parameters : Glucose
Lab exams: biochem(Glucose in mmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Creatinine
Lab exams: biochem( in μmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: SGOT/ASAT
Lab exams : biochem(in IU/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: SGOT/ALAT
Lab exams: biochem(in IU/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters:GGT
Lab exams: biochem(IU/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Alkalin phosphatase
Lab exams: biochem(IU/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: CPK
Lab exams: biochem(IU/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Total bilirubin
Lab exams: biochem(μmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Conjugated bilirubin
Lab exams: biochem(μmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Uric Acid
Lab exams: biochem(μmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Cholesterol
Lab exams: biochem(in mmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Triglycerides
Lab exams: biochem(in mmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Sodium
Lab exams: biochem(in mmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Potassium
Lab exams: biochem(in mmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters: Chlore
Lab exams: biochem( in mmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters:Calcium
Lab exams: biochem(in mmol/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters:Total protein
Lab exams: biochem(in g/L)
Measured: 127 days
Safety parameters assessed by biochemistry parameters:Albumin
Lab exams: biochem(in g/L)
Measured: 127 days
Safety parameters assessed by hormonology parameters
Laboratory exams : hormonology (Β-HCG)
Measured: 127 days
Safety parameters assessed by weight measurement
Physical exams : weight measurement in kilograms
Measured: 127 days
Safety parameters assessed by height measurement
Physical exams : height measurement in centimeters
Measured: 127 days
Battery of cognitive tasks
Cognitive evaluation
Measured: 43 days
Plasmatic quantification of inflammatory biomarkers concentration (CRPs)
Plasmatic quantification of concentration CRPs.
Measured: 43 days
Plasmatic quantification of inflammatory biomarkers concentration (Interleukins1, 6 and 10)
Plasmatic quantification of concentration of Interleukins 1, 6 and 10
Measured: 43 days
Blood quantification of gut microbiome
Metagenomic study of blood markers of gut mircrobiome
Measured: 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Jun 2019
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- There are 3 groups : * Placebo group will receive placebo during 42 days with antidepressant treatment in add-on. * Dose 1 during 42 days with antidepressant treatment in add-on. Upon IDMC recommendation after the first futility analysis (IDMC#5 13-Jun-2022), Dose 1 was stopped from the 17-Jun-2022. * Dose 2 during 42 days with antidepressant treatment in add-on.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mapreg
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Responsible party
- Sponsor
- Investigators
- Isabelle VILLEY, PhD, MBA, Study director, Mapreg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870776
- Sponsor's protocol ID
- MAP4343 / OP103617.MAP
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind,Controlled,Randomized Phase 2 Study of Efficacy,Safety,Pharmacokinetics& Pharmacodynamics of Daily Oral Administration of MAP4343 During 6 Weeks in Antidepressant Non-responders Patients Experiencing a Major Depressive Episode
- ClinicalTrials.gov ID
- NCT03870776
- Acronym / sponsor ID
- MAP4343 / OP103617.MAP
- Conditions
- Depression
- Keywords
- Depression, Resistant depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- MapregIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 12 Mar 2019 (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.
The study is a phase II, double-blind, randomized, placebo controlled, parallel, multicentric study in 110 patients with drug resistant depression.
Detailed description
This is a phase II, versus placebo, multicentre, double blind, randomized, parallel study in male or female patients with drug resistant depression.
This study targets the antidepressant non-responders' patients who have already experienced at least 2 antidepressant treatments with no success. It is estimated that about 2/3 of the patients treated with antidepressant drugs do not respond partially or completely to the actual conventional treatments (Selective Serotonin Reuptake Inhibitor and Serotonin and Norepinephrine Reuptake Inhibitor).
110 patients with drug resistant depression episode, aged 18 to 80 will be included in the study. They will be recruited from psychiatric consultations in the centers participating to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- There are 3 groups : * Placebo group will receive placebo during 42 days with antidepressant treatment in add-on. * Dose 1 during 42 days with antidepressant treatment in add-on. Upon IDMC recommendation after the first futility analysis (IDMC#5 13-Jun-2022), Dose 1 was stopped from the 17-Jun-2022. * Dose 2 during 42 days with antidepressant treatment in add-on.
| Arm | Type | Receives |
|---|---|---|
| Placebo group A | Placebo comparator | Drug: PlaceboPatients will receive the placebo during 42 days. |
| MAP4343 group B | Experimental | Drug: MAP4343Patients will receive daily dose 1 during 42 days. |
| MAP4343 group C | Experimental | Drug: MAP4343Patients will receive daily dose 2 during 42 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- TRD level from to 2 to 4 inclusive according to the Thase \& Rush classification;
- Patient experiencing a Major Depressive Episode (MDE) according to DSM-5 criteria. MDE can be isolated or recurrent. The diagnosis is based on Mini-International Neuropsychiatric Interview (MINI) test;
- Patient who received a previous antidepressant treatment (AD-Y) in monotherapy with vortioxetine, duloxetine or venlafaxine) at optimized dosages during 6 weeks prior to randomization, associated or not to AD-potentiator (quetiapine), are eligible.
- Hamilton Depression Rating Scale (HDRS) score > 21;
- Clinical Global Impressions scale (CGI) ≥ 4;
Key exclusion criteria (21 listed)
- MDE with mood congruent or not congruent psychotic characteristics;
- Patient hospitalized following the procedures: Psychiatric care at the request of another person (soins psychiatriques à la demande d'un tiers) or Psychiatric care at the request of the state representative (soins psychiatriques sur décision du représentant de l'Etat);
- Suicidal risk in the last month before randomization (C-SSRS: answer yes to the item 3 and/or answer yes to section suicidal behavior; MINI 5.00; suicidal risk section or item 3 of HDRS ≥ 3);
- History of other psychiatric disorder than DME except global anxiety, social phobia, panic troubles that should be accepted. In particular, patients who experienced a depressive state in bipolar disorder 1 or 2, schizophrenic or schizoaffective disorder should not be included;
- Presence or history of drug hypersensitivity, or certain allergic-prone condition diagnosed that could represent a risk factor for an allergic shock;
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 |
|---|---|---|
| MAP4343Daily oral administration of MAP4343 | Drug | MAP4343 group B, MAP4343 group C |
| PlaceboDaily oral administration of Placebo | Drug | Placebo group A |
Primary outcome
Hamilton Depression Rating Scale score evolution between baseline and D43
Time frame: 43 days
Assessment of HDRS score with 17 items with sides 0 to 2 or 0 to 4. The scores from 0 to 4 correspond respectively to symptoms: absent, doubtful or insignificant, light, moderate, important, those ranging from 0 to 2 to symptoms: absent, doubtful or slight, overt or severe. The total score consists of the addition of the individual scores.
61 secondary outcomes
Efficacy of treatment assessed by psychopathological evaluations with Hamilton Depression Rating Scale
Time frame: 43 days
Efficacy of treatment assessed by psychopathological evaluations with Montgomery and Asberg Depression rating Scale
Time frame: 43 days
Efficacy of treatment assessed by psychopathological evaluations with Brief Anxiety Scale
Time frame: 43 days
Efficacy of treatment assessed by psychopathological evaluations with Scale of Global Clinical Impressions
Time frame: 43 days
Efficacy of treatment assessed by psychopathological evaluations with Quick Inventory of Depressive Symptoms
Time frame: 43 days
Efficacy of treatment assessed by psychopathological evaluations with General Assessment Functioning
Time frame: 43 days
Pharmacokinetic assessments with observed maximum plasma concentration (Cmax);
Time frame: 127 days
Pharmacokinetic assessments with first time to reach Cmax (tmax);
Time frame: 127 days
Pharmacokinetic assessments with elimination rate constant (Kel);
Time frame: 127 days
Pharmacokinetic assessments with plasma elimination half-life (t1/2);
Time frame: 127 days
Pharmacokinetic assessments with plasma area under the plasma concentration-time curve from administration up to infinity with extrapolation of the terminal phase (AUCinf);
Time frame: 127 days
Pharmacokinetic assessments with percentage of extrapolated AUCinf (%AUCextra);
Time frame: 127 days
Pharmacokinetic assessments with volumn of distribution (Vd/F);
Time frame: 127 days
Pharmacokinetic assessments with Clearance (Cl/F);
Time frame: 127 days
Pharmacokinetic assessments with accumulation ratio (R);
Time frame: 127 days
Safety parameters assessed by the number of adverse events (AE)
Time frame: 127 days
Safety parameters assessed - Heart rate
Time frame: 127 days
Safety parameters assessed by blood pressure
Time frame: 127 days
Safety parameters assessed - 12-lead Electrocardiogramm
Time frame: 127 days
Safety parameters assessed - 12-lead ElectrocardiogrammPR;
Time frame: 127 days
Safety parameters assessed -12-lead Electrocardiogramm : QT
Time frame: 127 days
Safety parameters assessed - 12-lead Electrocardiogramm : QTc
Time frame: 127 days
Safety parameters assessed by hematology parameters : Haemoglobin
Time frame: 127 days
Safety parameters assessed by hematology parameters: Haematocrit
Time frame: 127 days
Safety parameters assessed by hematology parameters: Red blood cells
Time frame: 127 days
Safety parameters assessed by hematology parameters: White blood cells
Time frame: 127 days
Safety parameters assessed by hematology parameters:Neutrophils
Time frame: 127 days
Safety parameters assessed by hematology parameters: Eosinophils
Time frame: 127 days
Safety parameters assessed by hematology parameters: Basophils
Time frame: 127 days
Safety parameters assessed by hematology parameters: Lymphocytes
Time frame: 127 days
Safety parameters assessed by hematology parameters: Monocytes
Time frame: 127 days
Safety parameters assessed by hematology parameters: Platelets
Time frame: 127 days
Safety parameters assessed by hematology parameters: Reticulocytes;
Time frame: 127 days
Safety parameters assessed by red blood cells indices
Time frame: 127 days
Safety parameters assessed by hemostasis parameters
Time frame: 127 days
Safety parameters assessed by serology parameters
Time frame: 127 days
Safety parameters assessed by biochemistry parameters : Glucose
Time frame: 127 days
Safety parameters assessed by biochemistry parameters: Creatinine
Time frame: 127 days
Safety parameters assessed by biochemistry parameters: SGOT/ASAT
Time frame: 127 days
Safety parameters assessed by biochemistry parameters: SGOT/ALAT
Time frame: 127 days
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 31 Mar 2026.
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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.
Isabelle VILLEY, PhD, MBA study director
Mapreg
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAP4343 in people with Depression, run by Mapreg at 10 sites 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 23 inclusion and 21 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hamilton Depression Rating Scale score evolution between baseline and D43 (time frame: 43 days). 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 31 Mar 2026.