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