Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

Overview

About this study

To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Primary diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
  • Duration of current episode of depression ≥4 weeks and ≤3 years
  • Clinical Global Impression - Severity of Illness ≥ 4
  • Resistance to antidepressant treatment in a discrete illness episode
  • HAMD24 Item 1 ≥ 2 and total score ≥ 20
  • Subjects able to commit to protocol visit schedule
  • At the end of the baseline visit, subject must have a HAMD24 score of ≥ 18 and change in score may not be ≥ 25% decrease from that seen at the screening visit

Exclusion Criteria:

  • Prior TMS, vagus nerve stimulation (VNS), or electroconvulsive therapy (ECT)
  • Contraindication to TMS
  • Cardiac pacemakers, implanted medication pumps, intracardiac lines
  • History of neurological disorder
  • Unstable medical conditions
  • Any psychiatric disorder, which in the judgement of the Investigator may hinder the subject in completing the procedures required by the study protocol.
  • Significant acute suicide risk
  • Inability to locate and quantify a motor threshold
  • If sexually active female, not on an accepted method of birth control.
  • Diagnoses of the following conditions (current unless otherwise stated):
    • Depression secondary to a general medical condition, or substance induced:
    • Seasonal pattern of depression as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
    • Any psychotic disorder (lifetime), including history of schizophrenia, schizoaffective disorder, other psychosis, psychotic features in this or previous episodes, amnestic disorder,
    • Intellectually disabled,
    • Substance dependence or abuse within the past year (except nicotine or caffeine),
    • Bipolar disorder,
    • Obsessive compulsive disorder (lifetime),
    • Post-traumatic stress disorder (lifetime),
    • Eating disorder (lifetime).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Paul Croarkin, D.O., M.S.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20190365

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