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Completed

NCT Number: NCT01431001

Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression

The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash Alfred Psychiatry Research Centre, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Major depressive disorder (MDD)
  • Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode.
  • Will not become pregnant during study.

Exclusion criteria

  • Seizure disorder.
  • History of brain injury or active CNS disease.
  • Metal implants on or in brain, spinal cord, ear, eye or heart.
  • Current use of proconvulsant medications (e.g., bupropion).
  • Other significant psychiatric disorder.
  • Substance use disorder (not including caffeine or nicotine).
  • 7 or more failed treatment attempts for depression in one's lifetime.
  • Have failed to clinically remit to an adequate trial of ECT or TMS.

Treatment and study plan

Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Device

The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device

Primary outcomes

  1. Remission from depression

    Time frame: baseline through 4 weeks post

    Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post

Secondary outcomes

  1. Safety and tolerability of rTMS

    Time frame: baseline through 4 weeks post

    Determined by presence and absence of adverse events recorded daily

Sponsors and collaborators

Lead sponsor

Cervel Neurotech, Inc.

Industry

Registry information

Official study title

Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 9, 2011
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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