Major Depressive DisorderNCT05137197
Confirm the Effectiveness of Predictix Genetics Antidepressant -Guided Treatment in Adults With MDD
A study testing Predictix Genetics Antidepressant in people with Major Depressive Disorder, run by Taliaz Ltd. at 4 sites in 3 countries.
Trial summary
A randomized, controlled, prospective, multicenter, patient and rater blinded study with 2 arms: Treatment as Usual (TAU) and Predictix Guided Treatment (PGT). The study will compare the rate of treatment response and remission among both groups; TAU vs PGT. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Predictix Genetics Antidepressant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 4 Oct 2021to Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at the age of 18-75 years old at time of screening.
- Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0.
- MADRS score ≥22
- No other causes of depressive symptoms other than MDD.
- Ability to read, understand and sign an informed consent document.
- Not more than 2 past failed pharmacologic interventions for the current depressive episode.
- If subject is female and at reproductive age, she must be tested negative for pregnancy.
- If subject is female and at reproductive age with childbearing potential (i.e., not post-menopausal or surgically sterilized) she must agree to use adequate birth control methods during the whole study duration.
Who cannot join
- Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
- Patient requires antipsychotic medication or mood stabilizers (other than study medication), lithium, carbamazepine, valproate and other that may have an antidepressant effect.
- Electroconvulsive therapy (ECT) or transcranial magnetic stimulation therapy (TMS) conducted in the past or started within 90 days of screening or planned during the study.
- Nonpsychopharmacologic drugs with CNS effects that have been taken for less than 30 days prior to baseline.
- Subjects with a vagus nerve or deep brain stimulator.
- Patient is at substantial suicidal risk as determined by the Mini Neuropsychiatric Interview (MINI) Suicidality subscale for suicide attempts and/or judged by the treating physician.
Show all 13Show fewer
- Patient has any current unstable medical condition or surgical illness.
- Patient has history of seizure or convulsions.
- A current status of dependence to a drug or alcohol.
- Inadequate communication with the patient.
- Patient has participated in another clinical study in the last 30 days preceding this study.
- In the investigator's judgement, patient is not able to provide written informed consent and follow protocol requirements.
- Pregnant women.
Trial locations and contacts
4 sites in 3 countries.
Dekel Taliaz, PhD contact
4 sites in 3 countries
Belgium2 sites, 2 recruiting
- Recruiting
Psy Pluriel
Brussels
Daniel Souery, MD, dsouery@psypluriel.be
Daniel Soury, Dr
- Not yet recruiting
Psy Pluriel
Liège
William Pitchot, Prof, pitchotwilliam@gmail.com
William Pitchot, Prof
France1 site, 1 recruiting
- Not yet recruiting
Hospital Pitié Salpétrière
Paris
Bruno Millet, Prof.
Bertrand Saudreau, Dr.
Switzerland1 site, 1 recruiting
- Not yet recruiting
Hôpitaux Universitaires de Genève
Geneva
Othman Sentissi, MD, O.Sentissi@hcuge.ch
Othman Sentissi, MD
About this study
Official title: A Prospective, Randomized, Double-Blind (Subject and Rater) Controlled Study to Confirm the Effectiveness of Predictix Genetics Antidepressant -Guided Treatment in Adults With Major Depressive Disorder (MDD)
A randomized, controlled, prospective, multicenter, patient and rater blinded study with 2 arms: Treatment as Usual (TAU) and Predictix Guided Treatment (PGT). The study will compare the rate of treatment response and remission among both groups; TAU vs PGT.
Read the detailed description
A randomized, controlled, prospective, multicenter, patient and rater blinded study with 2 arms: Treatment as Usual (TAU) and Predictix Guided Treatment (PGT). The study will compare the rate of treatment response and remission among both groups; TAU vs PGT.
The study will enroll up to 354 eligible patients. An interim analysis is planned after 240 evaluable subjects complete the 8-week's visit. According to the interim analysis plan, the sample size may be increased to 522.
To participate in the study the subjects must be at least 18 years old and able to give a written informed consent after an oral and written explanation of the study aims and methods. The study sample will include female and male patients with major depression diagnosis according to DSM-5 and MINI criteria. For the detailed assessment of clinical severity of specific disorder and treatment effects, the following disorder-specific rating scales will be used: Montgomery-Asberg's Depression Rating Scale (MADRS), Clinical Global Impression scale (CGI), , Patient Health Questionnaire (PHQ-9) and Patient's Global Impression (PGI). Patients will be randomized into either the Predictix Guided Treatment (PGT) group or the Treatment as Usual (TAU) group. Randomization will be stratified based on the number of previous treatment failures for the current MDD episode to ensure balance of the treatment groups. Patients will be prospectively treated with approved antidepressant medication for a period of 8 weeks (defined as a treatment cycle) during and after which they will be assessed, and treatment success or failure will be determined. Maximum desired up-titration should be reached by week 2. Concomitant treatments that are permitted include: benzodiazepines for those who had no previous hypnotic treatment - Zolpidem 10 mg at night or for anxiety -no more than 10 mg/day Diazepam or equivalent; formal psychotherapy not started within a month before the beginning of the study; non-psychopharmacologic drugs with CNS effects if the patient has been receiving a stable dose of the drug for at least one month before baseline.
Patients will be defined as responders if the decrease in MADRS scores is at least 50% compared to baseline. The remitters will be defined if the scores are less than 10 on the MADRS. Patients who do not meet these criteria will be defined as non-responders and non-remitters respectively. Following the 8 weeks, patients in the TAU group will be offered PGT in an open-label extension of the study. Patients in the TAU and PGT groups will be followed for up to an additional 2 treatment cycles (of up to 8 weeks each).
A treatment cycle will include 4 visits: Screening, Baseline (on site visit), 4 and 8 weeks (Telephone visits). At least one completed cycle per patient is required for a patient to be included in the analysis as study completed.
- Conditions
- Major Depressive Disorder
- Being tested
- Predictix Genetics Antidepressant
- 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.
Predictix Genetics AntidepressantDevice
Predictix Genetics Antidepressant (PGA) is a software tool that is intended to support a clinician in choosing the most suitable antidepressant treatment/s for an individual patient diagnosed with MDD.
| Study group | Role | What they receive |
|---|---|---|
| TAU | No intervention | Treatment as Usual: The treating clinician will decide on what antidepressant to prescribe based on the clinical evaluation. |
| PGT | Active comparator | Predictix Guided Treatment: The treating clinician will decide on what antidepressant to prescribe based on clinical evaluation and the Predictix report Receives: Device: Predictix Genetics Antidepressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response is defined as a reduction from baseline of at least 50% (≥50%) in Montgomery-Asberg Depression Rating Scale (MADRS).
Measured: 8 weeks
Secondary outcomes (4)
Remission rate
Remission is defined as a Montgomery-Asberg Depression Rating Scale (MADRS) < 10
Measured: 8 weeks
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) over time.
Efficacy over time
Measured: 8 weeks
Time to response
Time to response
Measured: 8 weeks
Clinician Global Impression (CGI) score over time
Efficacy over time
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start4 Oct 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind (Subject and Rater) Controlled Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taliaz Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Souery, MD, Principal investigator, Psy Pluriel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137197
- Sponsor's protocol ID
- CL-01-MCS-001
- Status last verified
- Nov 2021
- First submitted
- 20 Oct 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taliaz D, Spinrad A, Barzilay R, Barnett-Itzhaki Z, Averbuch D, Teltsh O, Schurr R, Darki-Morag S, Lerer B. Optimizing prediction of response to antidepressant medications using machine learning and integrated genetic, clinical, and demographic data. Transl Psychiatry. 2021 Jul 8;11(1):381. doi: 10.1038/s41398-021-01488-3.
PubMed 34238923Taliaz D, Souery D. A New Characterization of Mental Health Disorders Using Digital Behavioral Data: Evidence from Major Depressive Disorder. J Clin Med. 2021 Jul 14;10(14):3109. doi: 10.3390/jcm10143109.
PubMed 34300275
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind (Subject and Rater) Controlled Study to Confirm the Effectiveness of Predictix Genetics Antidepressant -Guided Treatment in Adults With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT05137197
- Acronym / sponsor ID
- CL-01-MCS-001
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Taliaz Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Nov 2021 (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.
A randomized, controlled, prospective, multicenter, patient and rater blinded study with 2 arms: Treatment as Usual (TAU) and Predictix Guided Treatment (PGT). The study will compare the rate of treatment response and remission among both groups; TAU vs PGT.
Detailed description
A randomized, controlled, prospective, multicenter, patient and rater blinded study with 2 arms: Treatment as Usual (TAU) and Predictix Guided Treatment (PGT). The study will compare the rate of treatment response and remission among both groups; TAU vs PGT.
The study will enroll up to 354 eligible patients. An interim analysis is planned after 240 evaluable subjects complete the 8-week's visit. According to the interim analysis plan, the sample size may be increased to 522.
To participate in the study the subjects must be at least 18 years old and able to give a written informed consent after an oral and written explanation of the study aims and methods. The study sample will include female and male patients with major depression diagnosis according to DSM-5 and MINI criteria. For the detailed assessment of clinical severity of specific disorder and treatment effects, the following disorder-specific rating scales will be used: Montgomery-Asberg's Depression Rating Scale (MADRS), Clinical Global Impression scale (CGI), , Patient Health Questionnaire (PHQ-9) and Patient's Global Impression (PGI). Patients will be randomized into either the Predictix Guided Treatment (PGT) group or the Treatment as Usual (TAU) group. Randomization will be stratified based on the number of previous treatment failures for the current MDD episode to ensure balance of the treatment groups. Patients will be prospectively treated with approved antidepressant medication for a period of 8 weeks (defined as a treatment cycle) during and after which they will be assessed, and treatment success or failure will be determined. Maximum desired up-titration should be reached by week 2. Concomitant treatments that are permitted include: benzodiazepines for those who had no previous hypnotic treatment - Zolpidem 10 mg at night or for anxiety -no more than 10 mg/day Diazepam or equivalent; formal psychotherapy not started within a month before the beginning of the study; non-psychopharmacologic drugs with CNS effects if the patient has been receiving a stable dose of the drug for at least one month before baseline.
Patients will be defined as responders if the decrease in MADRS scores is at least 50% compared to baseline. The remitters will be defined if the scores are less than 10 on the MADRS. Patients who do not meet these criteria will be defined as non-responders and non-remitters respectively. Following the 8 weeks, patients in the TAU group will be offered PGT in an open-label extension of the study. Patients in the TAU and PGT groups will be followed for up to an additional 2 treatment cycles (of up to 8 weeks each).
A treatment cycle will include 4 visits: Screening, Baseline (on site visit), 4 and 8 weeks (Telephone visits). At least one completed cycle per patient is required for a patient to be included in the analysis as study completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blind (Subject and Rater) Controlled Study
| Arm | Type | Receives |
|---|---|---|
| TAU | No intervention | –Treatment as Usual: The treating clinician will decide on what antidepressant to prescribe based on the clinical evaluation. |
| PGT | Active comparator | Device: Predictix Genetics AntidepressantPredictix Guided Treatment: The treating clinician will decide on what antidepressant to prescribe based on clinical evaluation and the Predictix report |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female at the age of 18-75 years old at time of screening.
- Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0.
- MADRS score ≥22
- No other causes of depressive symptoms other than MDD.
- Ability to read, understand and sign an informed consent document.
Key exclusion criteria (13 listed)
- Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
- Patient requires antipsychotic medication or mood stabilizers (other than study medication), lithium, carbamazepine, valproate and other that may have an antidepressant effect.
- Electroconvulsive therapy (ECT) or transcranial magnetic stimulation therapy (TMS) conducted in the past or started within 90 days of screening or planned during the study.
- Nonpsychopharmacologic drugs with CNS effects that have been taken for less than 30 days prior to baseline.
- Subjects with a vagus nerve or deep brain stimulator.
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 |
|---|---|---|
| Predictix Genetics AntidepressantPredictix Genetics Antidepressant (PGA) is a software tool that is intended to support a clinician in choosing the most suitable antidepressant treatment/s for an individual patient diagnosed with MDD. | Device | PGT |
Primary outcome
Response rate
Time frame: 8 weeks
Response is defined as a reduction from baseline of at least 50% (≥50%) in Montgomery-Asberg Depression Rating Scale (MADRS).
4 secondary outcomes
Remission rate
Time frame: 8 weeks
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) over time.
Time frame: 8 weeks
Time to response
Time frame: 8 weeks
Clinician Global Impression (CGI) score over time
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Results publication: PubMed 34238923Taliaz D, Spinrad A, Barzilay R, Barnett-Itzhaki Z, Averbuch D, Teltsh O, Schurr R, Darki-Morag S, Lerer B. Optimizing prediction of response to antidepressant medications using machine learning and integrated genetic, clinical, and demographic data. Transl Psychiatry. 2021 Jul 8;11(1):381. doi: 10.1038/s41398-021-01488-3.
- Results publication: PubMed 34300275Taliaz D, Souery D. A New Characterization of Mental Health Disorders Using Digital Behavioral Data: Evidence from Major Depressive Disorder. J Clin Med. 2021 Jul 14;10(14):3109. doi: 10.3390/jcm10143109.
- Individual participant dataSharing planned: No
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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.
Dekel Taliaz, PhD contact
Daniel Souery, MD principal investigator
Psy Pluriel
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predictix Genetics Antidepressant in people with Major Depressive Disorder, run by Taliaz Ltd. at 4 sites in 3 countries.
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 8 inclusion and 13 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 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France, Switzerland. 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.
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 Dalia Dickman, PhD (+972545595951, dalia@taliazhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 8 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 NCT05137197, which also lists 2 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 30 Nov 2021.