Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predictix Antidepressant Software tool | Experimental | Predictix Antidepressant Software tool will be used when prescribed with a medication for their MDD, by their treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Usability n questionnaire will be analyzed | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dekel Taliaz, Dr. | Contact | +972-77- 3352506 | dekel@taliazhealth.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pitié Salpétrière | Paris | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed as an open label, one arm study
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided