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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04138290
• Other study ID #: CL-01-IBR-02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2019
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: Taliaz Ltd.
• Contact: Dekel Taliaz, Dr.
• Phone: +972-77- 3352506
• Email: dekel[@]taliazhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Hospital Pitié Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Taliaz Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate the effect of device use on patients' care outcomes in terms of economic burden and social impact	by analyzing the completed Work Productivity and Activity Impairment (WPAI) questionnaire.	8 weeks
Primary	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	Usability	Usability n questionnaire will be analyzed	8 weeks