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rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation (rTMS)
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 Teen, Adolescent, Depression, Transcranial Magnetic Stimulation, TMS

Eligibility Criteria

12 Years - 21 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 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
    • Zoloft (sertraline HCl) - 25mg to 200mg
  • Subjects able to attend at least 31 study visits at study site.
  • 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
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Part 1 Active

Part 1 Sham

Arm Description

Blinded, active repetitive transcranial magnetic stimulation

Blinded, sham repetitive transcranial magnetic stimulation

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2013
Last Updated
December 20, 2021
Sponsor
Paul E. Croarkin
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1. Study Identification

Unique Protocol Identification Number
NCT01804270
Brief Title
rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1
Official Title
A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Study & IDE was converted to Industry held, as opposed to initial investigator held.
Study Start Date
April 2013 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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 study will be the first to use a randomized, double-blinded, sham-controlled approach to the investigation of rTMS therapy for depressed adolescents. This approach will allow for the validation of rTMS treatment outcomes in the depressed adolescent population in a scientifically rigorous manner. The magnetic resonance (MR) spectroscopy pattern of rTMS response will be analyzed according to previously established protocols.
Detailed Description
Part 1 of the study aims to: Evaluate the antidepressant effects of daily, active rTMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode. Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla(3T), neurometabolic biomarkers at the beginning and end of each study phase. Define regional specificity [anterior cingulate (AC) and left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites(i.e. glutamate and glutamine) in adolescent depression. Study whether specific neurochemical resonances are associated with response, remission, and/or maintenance of improvement of clinical depressive symptoms when rTMS is used to treat adolescent depression.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Active
Arm Type
Active Comparator
Arm Description
Blinded, active repetitive transcranial magnetic stimulation
Arm Title
Part 1 Sham
Arm Type
Sham Comparator
Arm Description
Blinded, sham repetitive transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation (rTMS)
Other Intervention Name(s)
NeuroStar XPLOR
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
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
Within 5 days after Treatment 30 or Last Treatment
Title
Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in the Case 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 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.
Time Frame
Within 5 days after Treatment 30 or Last Treatment
Title
Mean Clinical Global Impression - Improvement (CGI-I) Score Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal)
Description
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.
Time Frame
Within 5 days after Treatment 30 or Last Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 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 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 Zoloft (sertraline HCl) - 25mg to 200mg Subjects able to attend at least 31 study visits at study site. 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
First Name & Middle Initial & Last Name & Degree
Mark A George, MD
Organizational Affiliation
Medical University of South Carolina
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
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
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
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1

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