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

Not Applicable

• Conditions: Major Depressive Disorder
• Interventions: Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS); Device: Open Label Active NeuroStar® TMS; Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)

• Registration Number: NCT02586688
• Lead Sponsor: Neuronetics

Brief Summary

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).

Detailed Description

To evaluate the antidepressant effects of daily, active TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode (Phase I).

Secondary:

To evaluate the acute and long term safety of TMS treatment in adolescent MDD subjects.

To evaluate the durability of benefit of TMS treatment over the course of 6 months in subjects who received clinical benefit from acute treatment course(s) (Phase III).

To evaluate the benefit of daily, active, open-label TMS in Phase I subjects who did not receive protocol-defined clinical benefit; as new acute treatment (sham to active) or as extended treatment course (blinded active to open label active) (Phase II).

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-05
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase I TMS Sham	Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)	Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Phase III Long-Term Follow up TMS Active	Open Label Active NeuroStar® TMS	Long term follow up with open label active TMS for retreatment as needed. Open label active NeuroStar® TMS.
Phase II Open Label Active TMS	Open Label Active NeuroStar® TMS	Open label active TMS coil. Open label active NeuroStar® TMS.
Phase I TMS Active	Active NeuroStar® Transcranial Magnetic Stimulation (TMS)	Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value.	6 weeks

Trial Locations

Locations (13)

Florida Clinical Practice Association, Inc.; 🇺🇸 Gainesville, Florida, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Anchor Neuroscience; 🇺🇸 Pensacola, Florida, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Beacon Medical Group; 🇺🇸 South Bend, Indiana, United States

Integrative Psychiatry; 🇺🇸 Louisville, Kentucky, United States

Rocky Mountain TMS; 🇺🇸 Grand Junction, Colorado, United States

Dothan Behavioral Medicine; 🇺🇸 Dothan, Alabama, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Sheppard Pratt Health System; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Cincinnati College of Medicine; 🇺🇸 Cincinnati, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States