Status:
UNKNOWN
Controlled Study to Evaluate the Safety and Efficacy of the Predictix Antidepressant Clinician Support Tool
Lead Sponsor:
Taliaz Ltd.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The study will compare two groups of patients: a control group of patients treated per the Standard of Care when prescribed with a medication for their Major depression disorder, versus a group of pat...
Detailed Description
The study will be comprised of two arms: 1. PGT arm - Predictix Antidepressant-guided treatment condition 2. SOC (control) arm - Standard of Care condition Eligible subjects will be assigned to one o...
Eligibility Criteria
Inclusion
- Male and female at the age of 18 - 75 years old at time of screening.
- MDD diagnosis per DSM V at screening visit or prior to screening visit.
- Rule out other causes of depressive symptoms other than MDD.
- Ability to read, understand and sign an informed consent document
- Female subjects at reproductive age that are tested negative for pregnancy
- Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods during the whole study duration
Exclusion
- Patient is currently on an antidepressant treatment.
- Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
- 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.
- Patient has participated in another clinical study in the last 30 days preceding this study.
- In the investigator's judgement, patient is not able to provide written informed consent and follow protocol requirements.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04031157
Start Date
January 1 2018
End Date
December 1 2020
Last Update
July 24 2019
Active Locations (2)
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1
Maccabi healthcare services
Tel Aviv, Israel
2
Maccabi healthcare services
Tel Aviv, Israel