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

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• 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.

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) .

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) .

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
• Primary Completion: 2018-01
• Study Completion: 2018-12
• Results First Submitted: 2021-12-14
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Results First Posted: 2025-06-12
• Last Update Posted: 2025-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value.	6 weeks	The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.HAM-D-24 24-item Hamilton Depression Rating Scale; Lower score is better (76 to 0)

Trial Locations

Locations (13)

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

UCLA; 🇺🇸 Los Angeles, California, United States

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

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

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

Anchor Neuroscience; 🇺🇸 Pensacola, Florida, United States

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

Integrative Psychiatry; 🇺🇸 Louisville, Kentucky, United States

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

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

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