Back to resultsPost 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
Primary Purpose
Major Depressive Disorder
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Predictix Antidepressant Software tool
Sponsored by
About this trial
This is an interventional supportive care trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Hospital Pitié Salpétrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Predictix Antidepressant Software tool
Arm Description
Predictix Antidepressant Software tool will be used when prescribed with a medication for their MDD, by their treating physician.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Usability
Usability n questionnaire will be analyzed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04138290
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taliaz Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
The study is designed as an open label, one arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Predictix Antidepressant Software tool
Arm Type
Experimental
Arm Description
Predictix Antidepressant Software tool will be used when prescribed with a medication for their MDD, by their treating physician.
Intervention Type
Device
Intervention Name(s)
Predictix Antidepressant Software tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
success rate of the Predictix tool
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Usability
Description
Usability n questionnaire will be analyzed
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
To evaluate the effect of device use on patients' care outcomes in terms of economic burden and social impact
Description
by analyzing the completed Work Productivity and Activity Impairment (WPAI) questionnaire.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dekel Taliaz, Dr.
Phone
+972-77- 3352506
Email
dekel@taliazhealth.com
Facility Information:
Facility Name
Hospital Pitié Salpétrière
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Millet, Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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