Last updated: November 29, 2021
Sponsor: Taliaz Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Affective Disorders
Depression (Major/severe)
Depression (Adult And Geriatric)
Treatment
N/AClinical Study ID
NCT05137197
CL-01-MCS-001
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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-5criteria 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 depressiveepisode.
- If subject is female and at reproductive age, she must be tested negative forpregnancy.
- If subject is female and at reproductive age with childbearing potential (i.e., notpost-menopausal or surgically sterilized) she must agree to use adequate birth controlmethods during the whole study duration.
Exclusion
Exclusion Criteria: EXCLUSION CRITERIA
- Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolardisorder, psychotic depression, geriatric depression).
- Patient requires antipsychotic medication or mood stabilizers (other than studymedication), lithium, carbamazepine, valproate and other that may have anantidepressant effect.
- Electroconvulsive therapy (ECT) or transcranial magnetic stimulation therapy (TMS)conducted in the past or started within 90 days of screening or planned during thestudy.
- Nonpsychopharmacologic drugs with CNS effects that have been taken for less than 30days prior to baseline.
- Subjects with a vagus nerve or deep brain stimulator.
- Patient is at substantial suicidal risk as determined by the Mini NeuropsychiatricInterview (MINI) Suicidality subscale for suicide attempts and/or judged by thetreating 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 thisstudy.
- In the investigator's judgement, patient is not able to provide written informedconsent and follow protocol requirements.
- Pregnant women.
Study Design
Total Participants: 354
Study Start date:
October 04, 2021
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Psy Pluriel
Brussels,
BelgiumActive - Recruiting
Psy Pluriel
Liège,
BelgiumSite Not Available
Hospital Pitié Salpétrière
Paris,
FranceSite Not Available
Hôpitaux Universitaires de Genève
Geneve,
SwitzerlandSite Not Available
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