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

Major Depressive Disorder Clinical Trial

Official title:

A Prospective, Randomized, Double-Blind (Subject and Rater) Controlled Study to Confirm the Effectiveness of Predictix Genetics Antidepressant -Guided Treatment in Adults With Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05137197
• Other study ID #: CL-01-MCS-001
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2021
• Source: Taliaz Ltd.
• Contact: Dalia Dickman, PhD
• Phone: +972545595951
• Email: dalia[@]taliazhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

The study will enroll up to 354 eligible patients. An interim analysis is planned after 240 evaluable subjects complete the 8-week's visit. According to the interim analysis plan, the sample size may be increased to 522.

To participate in the study the subjects must be at least 18 years old and able to give a written informed consent after an oral and written explanation of the study aims and methods. The study sample will include female and male patients with major depression diagnosis according to DSM-5 and MINI criteria. For the detailed assessment of clinical severity of specific disorder and treatment effects, the following disorder-specific rating scales will be used: Montgomery-Asberg's Depression Rating Scale (MADRS), Clinical Global Impression scale (CGI), , Patient Health Questionnaire (PHQ-9) and Patient's Global Impression (PGI). Patients will be randomized into either the Predictix Guided Treatment (PGT) group or the Treatment as Usual (TAU) group. Randomization will be stratified based on the number of previous treatment failures for the current MDD episode to ensure balance of the treatment groups. Patients will be prospectively treated with approved antidepressant medication for a period of 8 weeks (defined as a treatment cycle) during and after which they will be assessed, and treatment success or failure will be determined. Maximum desired up-titration should be reached by week 2. Concomitant treatments that are permitted include: benzodiazepines for those who had no previous hypnotic treatment - Zolpidem 10 mg at night or for anxiety -no more than 10 mg/day Diazepam or equivalent; formal psychotherapy not started within a month before the beginning of the study; non-psychopharmacologic drugs with CNS effects if the patient has been receiving a stable dose of the drug for at least one month before baseline.

Patients will be defined as responders if the decrease in MADRS scores is at least 50% compared to baseline. The remitters will be defined if the scores are less than 10 on the MADRS. Patients who do not meet these criteria will be defined as non-responders and non-remitters respectively. Following the 8 weeks, patients in the TAU group will be offered PGT in an open-label extension of the study. Patients in the TAU and PGT groups will be followed for up to an additional 2 treatment cycles (of up to 8 weeks each).

A treatment cycle will include 4 visits: Screening, Baseline (on site visit), 4 and 8 weeks (Telephone visits). At least one completed cycle per patient is required for a patient to be included in the analysis as study completed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female at the age of 18-75 years old at time of screening.

2. Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0.

3. MADRS score =22

4. No other causes of depressive symptoms other than MDD.

5. Ability to read, understand and sign an informed consent document.

6. Not more than 2 past failed pharmacologic interventions for the current depressive episode.

7. If subject is female and at reproductive age, she must be tested negative for pregnancy.

8. 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.

Exclusion Criteria:

EXCLUSION CRITERIA

1. Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression).

2. Patient requires antipsychotic medication or mood stabilizers (other than study medication), lithium, carbamazepine, valproate and other that may have an antidepressant effect.

3. 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.

4. Nonpsychopharmacologic drugs with CNS effects that have been taken for less than 30 days prior to baseline.

5. Subjects with a vagus nerve or deep brain stimulator.

6. 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.

7. Patient has any current unstable medical condition or surgical illness.

8. Patient has history of seizure or convulsions.

9. A current status of dependence to a drug or alcohol.

10. Inadequate communication with the patient.

11. Patient has participated in another clinical study in the last 30 days preceding this study.

12. In the investigator's judgement, patient is not able to provide written informed consent and follow protocol requirements.

13. Pregnant women.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Predictix Genetics Antidepressant
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.

Locations

Country	Name	City	State
Belgium	Psy Pluriel	Brussels
Belgium	Psy Pluriel	Liège
France	Hospital Pitié Salpétrière	Paris
Switzerland	Hôpitaux Universitaires de Genève	Geneve

Sponsors (1)

Lead Sponsor	Collaborator
Taliaz Ltd.

Countries where clinical trial is conducted

Belgium,  France,  Switzerland, 

References & Publications (2)

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). pii: 3109. doi: 10.3390/jcm10143109. — View Citation

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. Tran — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Remission rate	Remission is defined as a Montgomery-Asberg Depression Rating Scale (MADRS) < 10	8 weeks
Secondary	Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) over time.	Efficacy over time	8 weeks
Secondary	Time to response	Time to response	8 weeks
Secondary	Clinician Global Impression (CGI) score over time	Efficacy over time	8 weeks