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

Taliaz

Status and phase

Unknown

Phase 4

Conditions

Major Depressive Disorder

Treatments

Device: Predictix Antidepressant Software tool

Study type

Interventional

Funder types

Industry

Identifiers

NCT04138290

CL-01-IBR-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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