Status:
UNKNOWN
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
Lead Sponsor:
Taliaz Ltd.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 f...
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04138290
Start Date
December 1 2019
End Date
December 1 2020
Last Update
October 24 2019
Active Locations (1)
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1
Hospital Pitié Salpétrière
Paris, France