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

NCT04138290 | Unknown Phase 4

• 1 other identifier: CL-01-IBR-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Usability

  8 weeks

Other Outcomes (1)

• To evaluate the effect of device use on patients' care outcomes in terms of economic burden and social impact

  8 weeks

Study Arms (1)

Predictix Antidepressant Software tool

EXPERIMENTAL

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

Device: Predictix Antidepressant Software tool

Interventions

Predictix Antidepressant Software tool 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.

Predictix Antidepressant Software tool

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taliaz Ltd.: lead

Study Sites (1)

Hospital Pitié Salpétrière

Paris, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Dekel Taliaz, Dr.

CONTACT

+972-77- 3352506; dekel@taliazhealth.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is designed as an open label, one arm study

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 24, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)