Controlled Study to Evaluate the Safety and Efficacy of the Predictix Antidepressant Clinician Support Tool

NCT04031157 | Unknown

• 1 other identifier: CL-02-PRT-02
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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 patients that used the Predictix Antidepressant tool when prescribed with a medication for their Major depression disorder by their treating physician. Success will be measured by the number (proportion) of responders per group.

Conditions

Major Depressive Disorder

Keywords

MDD

Outcome Measures

Primary Outcomes (1)

• Overall Response rate in the PGT and SOC groups

  Overall Response rate with and without the use of the Predictix Antidepressant software tool. Response is measures as at least 45% reduction in symptoms severity, measured by the Quick Inventory of Depressive Symptomatology (QIDS 16)

  12 weeks

Secondary Outcomes (3)

• Change from baseline in Quick Inventory of Depressive Symptomatology( QIDS 16) self reported score

  12 weeks

• Usability and satisfaction of the Predictix tool

  12 weeks

• Economic burden* and social impact on patients, employers, the health system and payers

  12 month

Study Arms (2)

PGT arm

EXPERIMENTAL

Predictix Antidepressant-guided treatment condition

Device: Predictix Antidepressant

soc arm

NO INTERVENTION

Standard of Care condition

Interventions

Predictix Antidepressant DEVICE

Predictix Antidepressant guided treatment

PGT arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taliaz Ltd.: lead

Study Sites (2)

Maccabi healthcare services

Tel Aviv, Israel

RECRUITING

Maccabi healthcare services

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Dekel Taliaz, Dr.

CONTACT

+972-77- 3352506; dekel@taliazhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: July 24, 2019
• Study Start: January 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)