Major Depressive DisorderPhase 4NCT04138290
Post Marketing Study for the Evaluation of Predictix Antidepressant Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive Disorder
A Phase 4 study testing Predictix Antidepressant Software tool in people with Major Depressive Disorder, run by Taliaz Ltd. at 1 site in France.
Trial summary
The study is designed as an open label, one arm study. Up to 30 eligible patients will be enrolled, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician. 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 Antidepressant Software tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2019to Dec 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female at the age of 18 - 75 years old
- Indication of MDD diagnosis per DSM V
- Rule out other causes of depressive symptoms other than MDD apart from General Anxiety Disorder as authentified by the MINI*) (by Sheehan and Lecrubier ).
- Up to a maximum of 15 completed GAD pts
- Ability to read, understand and sign an informed consent document
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
- Patient is at substantial suicidal risk as judged by the treating physician
- Patient has attempted suicide in the past year.
- Patient has any current unstable medical condition or surgical illness
- Patient has history of seizure or convulsions.
Show all 10Show fewer
- Patient has history of drug abuse or alcoholism in the last 6 months
- Inadequate communication with the patient
- In the investigator's judgement, patient is not able to provide written informed consent
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Post Marketing Surveillance Study Study for the Evaluation of the Safety and Efficacy of the Predictix Antidepressant (PAD) Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive Disorder
The study is designed as an open label, one arm study. Up to 30 eligible patients will be enrolled, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.
Visits will include the completion of several questionnaires designed to answer the study objectives, either as self-reported by the subjects and/ or by the clinician.
Read the detailed description
The study will enroll up to 30 eligible patients, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.
A treatment cycle will include four to five visits: Information consent and oral sampling, Baseline, 4 and 8 weeks. At least one completed cycle per patient is required for a patient to be included in the analysis as study completed.
The treating physician will review and approve each subject's eligibility prior to his/ her entrance to the study and will review the Predictix Antidepressant software tool report prior to treatment start.
Visits will include the completion of the Taliaz Ltd. Physician Form and several questionnaires designed to answer the study objectives Usability and satisfaction questionnaire/s will be analyzed for Usefulness, Satisfaction, Ease of Use and Learnability of the system.
- Conditions
- Major Depressive Disorder
- Being tested
- Predictix Antidepressant Software tool
- 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 Antidepressant Software toolDevice
Predictix Antidepressant is a stand-alone software tool based on a patients' genetic panel, clinical, demographic and behavioral inputs, intended to support a clinician in choosing the most suitable antidepressant treatment/s for an individual patient diagnosed with Major Depressive Disorder.
| Study group | Role | What they receive |
|---|---|---|
| Predictix Antidepressant Software tool | Experimental | Predictix Antidepressant Software tool will be used when prescribed with a medication for their MDD, by their treating physician. Receives: Device: Predictix Antidepressant Software tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of the Predictix tool
A success will be defined as a score of 3 and below in the total improvement: measured by the CGI last measured value compared to Baseline, as well as a >50% improvement measured by the QIDS16, under a specific medication cycle regimen.
Measured: 8 weeks
Secondary outcomes (1)
Usability
Usability n questionnaire will be analyzed
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 posted24 Oct 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is designed as an open label, one arm study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taliaz Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138290
- Sponsor's protocol ID
- CL-01-IBR-02
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Post Marketing Surveillance Study Study for the Evaluation of the Safety and Efficacy of the Predictix Antidepressant (PAD) Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04138290
- Acronym / sponsor ID
- CL-01-IBR-02
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taliaz Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Oct 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 designed as an open label, one arm study. Up to 30 eligible patients will be enrolled, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.
Visits will include the completion of several questionnaires designed to answer the study objectives, either as self-reported by the subjects and/ or by the clinician.
Detailed description
The study will enroll up to 30 eligible patients, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.
A treatment cycle will include four to five visits: Information consent and oral sampling, Baseline, 4 and 8 weeks. At least one completed cycle per patient is required for a patient to be included in the analysis as study completed.
The treating physician will review and approve each subject's eligibility prior to his/ her entrance to the study and will review the Predictix Antidepressant software tool report prior to treatment start.
Visits will include the completion of the Taliaz Ltd. Physician Form and several questionnaires designed to answer the study objectives Usability and satisfaction questionnaire/s will be analyzed for Usefulness, Satisfaction, Ease of Use and Learnability of the system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is designed as an open label, one arm study
| Arm | Type | Receives |
|---|---|---|
| Predictix Antidepressant Software tool | Experimental | Device: Predictix Antidepressant Software toolPredictix Antidepressant Software tool will be used when prescribed with a medication for their MDD, by their treating physician. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female at the age of 18 - 75 years old
- Indication of MDD diagnosis per DSM V
- Rule out other causes of depressive symptoms other than MDD apart from General Anxiety Disorder as authentified by the MINI*) (by Sheehan and Lecrubier ).
- Up to a maximum of 15 completed GAD pts
- Ability to read, understand and sign an informed consent document
Key exclusion criteria (10 listed)
- Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression)
- Patient requires antipsychotic medication or mood stabilizers
- Patient is at substantial suicidal risk as judged by the treating physician
- Patient has attempted suicide in the past year.
- Patient has any current unstable medical condition or surgical illness
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 Antidepressant Software toolPredictix Antidepressant is a stand-alone software tool based on a patients' genetic panel, clinical, demographic and behavioral inputs, intended to support a clinician in choosing the most suitable antidepressant treatment/s for an individual patient diagnosed with Major Depressive Disorder. | Device | Predictix Antidepressant Software tool |
Primary outcome
success rate of the Predictix tool
Time frame: 8 weeks
A success will be defined as a score of 3 and below in the total improvement: measured by the CGI last measured value compared to Baseline, as well as a >50% improvement measured by the QIDS16, under a specific medication cycle regimen.
1 secondary outcome
Usability
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 24 Oct 2019.
- 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.
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 Predictix Antidepressant Software tool in people with Major Depressive Disorder, run by Taliaz Ltd. 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 10 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 24 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dekel Taliaz, Dr. (+972-77- 3352506, dekel@taliazhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of the Predictix tool (time frame: 8 weeks). 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 24 Oct 2019.