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
Overview
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 Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Supportive Care
- Masking: None (Open Label)
- Study Primary Completion Date: December 2020
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.
Interventions
- 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.
Arms, Groups and Cohorts
- Experimental: Predictix Antidepressant Software tool
- Predictix Antidepressant Software tool will be used when prescribed with a medication for their MDD, by their treating physician.
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Usability
- Time Frame: 8 weeks
- Usability n questionnaire will be analyzed
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Taliaz Ltd.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Contact(s)
- Dekel Taliaz, Dr., +972-77- 3352506, dekel@taliazhealth.com
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