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Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD) | Clinical Trials | Clareo Health

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Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)

NCT02805881•Neurolief Ltd.

View on ClinicalTrials.gov

Summary

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject is capable of understanding the study and to sign an informed consent.
•Subject is between the ages of 18 to 65 years old.
•Unipolar major depressive disorder
•Score on the Hamilton Depression Rating Scale (HDRS21) \> 22
•Current MDD episode \>3 months
•Nonresponse with \>6 week use of one to six antidepressant in current episode

Exclusion Criteria

•History of neurosurgical interventions.
•Subjects with metal implants or shrapnel in their head, except for dental implants.
•Skin lesion or inflammation at the region of the stimulating electrodes.
•Pregnancy or Lactation.
•Women of reproductive age not using efficient contraceptive method.
•History of cerebrovascular event.
•Psychotic or bipolar depression
•History of schizophrenia, schizoaffective disorder or other non-mood disorder psychosis
•Current delirium, dementia, amnestic disorder or other cognitive disorders
•Clinically significant current suicidal intent as assessed by the investigator team.
+4 more criteria

Locations (1)

Beer- Yakov Nees-Ziona Mental Health Center

Ness Ziona, Israel

Key Dates

Start Date

May 1, 2016

Primary Completion Date

July 1, 2021

Completion Date

July 1, 2021

Last Updated

September 5, 2021

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Neurolief system

DEVICE

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)