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A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)

C

Cervel Neurotech

Status

Completed

Conditions

Depressive Disorder, Major

Treatments

Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT01909232
CN-CFS-TRMD-2

Details and patient eligibility

About

The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.

Enrollment

92 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Current major depressive disorder (MDD)
  • Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode
  • On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study
  • Weight less than 350 pounds

Exclusion criteria

  • Current major depressive disorder episode of more than three years
  • Seizure disorder
  • History of brain injury, stroke or active central nervous system disease
  • Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe
  • Active suicidal intent or plan
  • Other significant psychiatric disorder
  • Alcohol or substance dependence or abuse
  • Prior treatment with transcranial magnetic stimulation
  • Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation
  • If female, pregnant or lactating or planning to become pregnant within the next three months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

92 participants in 2 patient groups

Active rTMS treatment
Experimental group
Description:
Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Treatment:
Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Sham rTMS treatment
Sham Comparator group
Description:
Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Treatment:
Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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