Clinical trial NCT02586688: Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Official title: A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: child depression
depression
Transcranial Magnetic Stimulation
Adolescent Major Depressive Disorder
TMS
adolescent depression
Lead sponsor: Neuronetics
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 112
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) .

Eligibility criteria: 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).

Primary outcomes:
measure: Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Dothan Behavioral Medicine
state: Alabama
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Grand Junction
country: United States
facility: Rocky Mountain TMS
state: Colorado
city: Gainesville
country: United States
facility: Florida Clinical Practice Association, Inc.
state: Florida
city: Pensacola
country: United States
facility: Anchor Neuroscience
state: Florida
city: South Bend
country: United States
facility: Beacon Medical Group
state: Indiana
city: Louisville
country: United States
facility: Integrative Psychiatry
state: Kentucky
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Mayo Clinic
name: Paul Croarkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neuronetics
name: Karen Heart
role: STUDY_DIRECTOR
References:
citation: O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
citation: Carpenter LL, Janicak PG, Aaronson ST, Boyadjis T, Brock DG, Cook IA, Dunner DL, Lanocha K, Solvason HB, Demitrack MA. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012 Jul;29(7):587-96. doi: 10.1002/da.21969. Epub 2012 Jun 11.
citation: Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9. doi: 10.4088/JCP.11m07003.