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
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Taliaz Ltd.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- success rate of the Predictix tool
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
success rate of the Predictix tool
Time Frame: 8 weeks
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.
Secondary Outcomes
- Usability(8 weeks)