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Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
Paul E. Croarkin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Adolescent Depression, Transcranial Magnetic Stimulation

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
  • Pretreatment CDRS-R Raw score ≥ 40
  • Age is at least 13 and less than 19 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
    • Zoloft (sertraline HCl) - 25mg to 200mg
  • Subjects able to attend at least 31 study visits at Mayo Clinic - Rochester
  • Willing to provide informed assent (adolescent) and informed consent (family)

Exclusion Criteria:

  • Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.
  • Prior rTMS, 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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Magnetic Stimulation

Arm Description

Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 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.

Outcomes

Primary Outcome Measures

Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases 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.

Secondary Outcome Measures

Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)
The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).
The Clinical Global Impression - Improvement (CGI-I)
The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).

Full Information

First Posted
December 27, 2011
Last Updated
April 20, 2016
Sponsor
Paul E. Croarkin
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1. Study Identification

Unique Protocol Identification Number
NCT01502033
Brief Title
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
Official Title
An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul E. Croarkin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study aims to test the safety and effectiveness of repetitive transcranial magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how rTMS treatment affects the neurobiology of teens with depression.
Detailed Description
This study aims to: Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria for major depressive disorder, single or recurrent episode. Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla (3T), the regional specificity [anterior cingulate (AC) vs. left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites (glutamate and glutamine) in adolescent depression and study whether glutamine resonances are associated with response or remission of clinical depressive symptoms when rTMS is used to treat adolescent depression. Evaluate the accuracy of an efficient method for locating the F3 position (i.e., L-DLPFC) through comparison with magnetic resonance imaging (MRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Adolescent Depression, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation
Arm Type
Experimental
Arm Description
Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 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.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
NeuroStar
Intervention Description
30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment
Primary Outcome Measure Information:
Title
Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)
Description
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.
Time Frame
5 days of Treatment 30 or Last Treatment
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)
Description
The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).
Time Frame
Within 5 days of Treatment 30 or Last Treatment
Title
The Clinical Global Impression - Improvement (CGI-I)
Description
The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).
Time Frame
Within 5 days of 30 treatments or after last treatment in case of early withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features Pretreatment CDRS-R Raw score ≥ 40 Age is at least 13 and less than 19 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 Zoloft (sertraline HCl) - 25mg to 200mg Subjects able to attend at least 31 study visits at Mayo Clinic - Rochester Willing to provide informed assent (adolescent) and informed consent (family) Exclusion Criteria: Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications. Prior rTMS, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E Croarkin, DO
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24376426
Citation
Wall CA, Croarkin PE, McClintock SM, Murphy LL, Bandel LA, Sim LA, Sampson SM. Neurocognitive effects of repetitive transcranial magnetic stimulation in adolescents with major depressive disorder. Front Psychiatry. 2013 Dec 12;4:165. doi: 10.3389/fpsyt.2013.00165. eCollection 2013.
Results Reference
background
PubMed Identifier
31634515
Citation
Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18.
Results Reference
derived
PubMed Identifier
26849202
Citation
Wall CA, Croarkin PE, Maroney-Smith MJ, Haugen LM, Baruth JM, Frye MA, Sampson SM, Port JD. Magnetic Resonance Imaging-Guided, Open-Label, High-Frequency Repetitive Transcranial Magnetic Stimulation for Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):582-9. doi: 10.1089/cap.2015.0217. Epub 2016 Feb 5.
Results Reference
derived

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Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens

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