rTMS for Depressed Teens: A Sham-Controlled Trial, Part 2

NCT01804296 | Terminated Results DMC FDA Device

• 1 other identifier: 12-003248 Part 2
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This research proposal aims to better understand the neurobiology of depression in adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically impact brain function and mood. This investigation also proposes the first study to examine the efficacy of rTMS maintenance therapy in adolescents who have met clinical criteria following acute rTMS treatment. The magnetic resonance (MR) spectroscopy pattern of rTMS response will be analyzed according to previously established protocols.

Conditions

Major Depressive Disorder

Keywords

Teen; Adolescent; Depression; Transcranial Magnetic Stimulation; TMS

Outcome Measures

Primary Outcomes (3)

• Mean Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal)

  The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.

  Within 5 days after Treatment 30 or Last Treatment

• Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal)

  The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates the severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.

  Within 5 days after Treatment 30 or Last Treatment

• Mean Clinical Global Impression - Improvement (CGI-I) Score Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal)

  The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates the degree to which the severity of the subject's depressive illness has improved or worsened compared to baseline severity.

  Within 5 days after Treatment 30 or Last Treatment

Study Arms (1)

Part 2 Active

EXPERIMENTAL

Open-label, active repetitive transcranial magnetic stimulation

Device: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

Repetitive transcranial magnetic stimulation (rTMS) DEVICE

Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.

Also known as: NeuroStar

Part 2 Active

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Successful completion of Part 1 of study
• Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
• Age is at least 12 and less than 22 years
• Ongoing, stable dose antidepressant therapy for at least 6 weeks to include the following antidepressants (with dosing range):
• Celexa (citalopram hydrobromide) - 10 to 60mg
• Cymbalta (duloxetine) - 40mg to 120mg
• Desyrel (trazodone HCl) - 12.5mg to 150mg
• Effexor (venlafaxine HCl) - 37.5mg to 300mg
• Luvox (fluvoxamine maleate) - 25mg to 200mg
• Lexapro (escitalopram oxalate) - 10mg to 40mg
• Paxil (paroxetine HCl) - 10mg to 50mg
• Pristiq (desvenlafaxine) - 50mg to 100mg
• Prozac (fluoxetine HCl) - 10mg to 80mg
• Remeron (mirtazapine) - 7.5mg to 45mg
• Savella (milnacipran HCl) - 25mg to 200mg

You may not qualify if:

• Withdrew from treatment of study Part 1
• Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.
• Prior vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT)
• Contraindication to MRI
• Contraindication to rTMS (history of neurological disorder such as seizures, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \>15 minutes, history of stroke, family history of epilepsy, intracardiac lines, Anticoagulant, immune suppressive and/or chemotherapy, or those who received any of these therapies within 3 months before enrollment in the study Unstable medication conditions such as hematological or infectious (e.g., human immunodeficiency virus-HIV) disorders, implanted electronic device, metal in the head, or pregnancy)
• History of schizophrenia, schizoaffective disorder, other \[non mood disorder\] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder
• History of autoimmune, endocrine, viral, or vascular disorder.
• Unstable cardiac disease, uncontrolled hypertension, or sleep apnea
• Active suicidal intent or plan, or history of attempt within the past 6 months

Sponsors & Collaborators

• Paul E. Croarkin: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Paul E. Croarkin, D.O., M.S.
• Organization: Mayo Clinic

Croarkin.Paul@mayo.edu

507-293-2557

Study Officials

• Paul E Croarkin, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Mark A George, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Child and Adolescent Psychiatry

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 5, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 19, 2022
• Results First Posted: January 19, 2022

Record last verified: 2021-12

Locations

US (2)