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

Completed · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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).

Key facts

Study ID

NCT02586688

Run by

Neuronetics

People needed

112

Starts

2015-10-01

Expected to finish

2018-12-01

Last updated by the study team

2025-06-12

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• 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
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.