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

NCT ID: NCT04138290

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2020-12-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Predictix Antidepressant Software tool

Predictix Antidepressant Software tool will be used when prescribed with a medication for their MDD, by their treating physician.

Group Type: EXPERIMENTAL

Predictix Antidepressant Software tool

Intervention Type: DEVICE

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.

Interventions

Predictix Antidepressant Software tool

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taliaz Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Pitié Salpétrière

Paris, , France

Countries

France

Central Contacts

Dekel Taliaz, Dr.

Role: CONTACT

dekel@taliazhealth.com

+972-77- 3352506

Facility Contacts

Bruno Millet, Prof.

Role: primary

Other Identifiers

CL-01-IBR-02

Identifier Type: -

Identifier Source: org_study_id