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

Neuronetics

Status: Unknown

Conditions: Major Depressive Disorder

Treatments: Device: Open Label Active NeuroStar® TMS; Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS); Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02586688

44-02219-000

Details and patient eligibility

About

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).

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups

Phase I TMS Active

Active Comparator group

Description:

Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)

Treatment:

Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)

Phase I TMS Sham

Sham Comparator group

Description:

Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)

Treatment:

Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)

Phase II Open Label Active TMS

Other group

Description:

Open label active TMS coil. Open label active NeuroStar® TMS.

Treatment:

Device: Open Label Active NeuroStar® TMS

Phase III Long-Term Follow up TMS Active

Other group

Description:

Long term follow up with open label active TMS for retreatment as needed. Open label active NeuroStar® TMS.

Treatment:

Device: Open Label Active NeuroStar® TMS