Confirm the Effectiveness of Predictix Genetics Antidepressant -Guided Treatment in Adults With MDD

NCT05137197 | Unknown

• 1 other identifier: CL-01-MCS-001
• Study Type: interventional
• Target: 354
• Locations: 3 countries
• Sites: 4

Brief Summary

A randomized, controlled, prospective, multicenter, patient and rater blinded study with 2 arms: Treatment as Usual (TAU) and Predictix Guided Treatment (PGT). The study will compare the rate of treatment response and remission among both groups; TAU vs PGT.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Response rate

  Response is defined as a reduction from baseline of at least 50% (≥50%) in Montgomery-Asberg Depression Rating Scale (MADRS).

  8 weeks

Secondary Outcomes (4)

• Remission rate

  8 weeks

• Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) over time.

  8 weeks

• Time to response

  8 weeks

• Clinician Global Impression (CGI) score over time

  8 weeks

Study Arms (2)

TAU

NO INTERVENTION

Treatment as Usual: The treating clinician will decide on what antidepressant to prescribe based on the clinical evaluation.

PGT

ACTIVE COMPARATOR

Predictix Guided Treatment: The treating clinician will decide on what antidepressant to prescribe based on clinical evaluation and the Predictix report

Device: Predictix Genetics Antidepressant

Interventions

Predictix Genetics Antidepressant DEVICE

Predictix Genetics Antidepressant (PGA) is a software tool that is intended to support a clinician in choosing the most suitable antidepressant treatment/s for an individual patient diagnosed with MDD.

PGT

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 or female at the age of 18-75 years old at time of screening.
• Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0.
• MADRS score ≥22
• No other causes of depressive symptoms other than MDD.
• Ability to read, understand and sign an informed consent document.
• Not more than 2 past failed pharmacologic interventions for the current depressive episode.
• If subject is female and at reproductive age, she must be tested negative for pregnancy.
• If subject is female and at reproductive age with childbearing potential (i.e., not post-menopausal or surgically sterilized) she must agree to use adequate birth control methods during the whole study duration.

You may not qualify if:

• Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
• Patient requires antipsychotic medication or mood stabilizers (other than study medication), lithium, carbamazepine, valproate and other that may have an antidepressant effect.
• Electroconvulsive therapy (ECT) or transcranial magnetic stimulation therapy (TMS) conducted in the past or started within 90 days of screening or planned during the study.
• Nonpsychopharmacologic drugs with CNS effects that have been taken for less than 30 days prior to baseline.
• Subjects with a vagus nerve or deep brain stimulator.
• Patient is at substantial suicidal risk as determined by the Mini Neuropsychiatric Interview (MINI) Suicidality subscale for suicide attempts and/or judged by the treating physician.
• Patient has any current unstable medical condition or surgical illness.
• Patient has history of seizure or convulsions.
• A current status of dependence to a drug or alcohol.
• 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.
• Pregnant women.

Sponsors & Collaborators

• Taliaz Ltd.: lead

Study Sites (4)

Psy Pluriel

Brussels, Belgium

RECRUITING

Psy Pluriel

Liège, Belgium

NOT YET RECRUITING

Hospital Pitié Salpétrière

Paris, France

NOT YET RECRUITING

Hôpitaux Universitaires de Genève

Geneva, Switzerland

NOT YET RECRUITING

Related Publications (2)

• Taliaz D, Spinrad A, Barzilay R, Barnett-Itzhaki Z, Averbuch D, Teltsh O, Schurr R, Darki-Morag S, Lerer B. Optimizing prediction of response to antidepressant medications using machine learning and integrated genetic, clinical, and demographic data. Transl Psychiatry. 2021 Jul 8;11(1):381. doi: 10.1038/s41398-021-01488-3.

  PMID: 34238923 RESULT

• Taliaz D, Souery D. A New Characterization of Mental Health Disorders Using Digital Behavioral Data: Evidence from Major Depressive Disorder. J Clin Med. 2021 Jul 14;10(14):3109. doi: 10.3390/jcm10143109.

  PMID: 34300275 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Daniel Souery, MD

  Psy Pluriel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia Dickman, PhD

CONTACT

+972545595951; dalia@taliazhealth.com

Dekel Taliaz, PhD

CONTACT

dekel@taliazhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blind (Subject and Rater) Controlled Study

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 30, 2021
• Study Start: October 4, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); CH (1); FR (1)