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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01804270
Recruitment Status : Terminated (Study & IDE was converted to Industry held, as opposed to initial investigator held.)
First Posted : March 5, 2013
Results First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Paul E. Croarkin, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Device: Repetitive transcranial magnetic stimulation (rTMS)
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part 1 Active Part 1 Sham
Hide Arm/Group Description

Blinded, active repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.

Blinded, sham repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.
Period Title: Overall Study
Started 2 4
Completed 1 3
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Part 1 Active Part 1 Sham Total
Hide Arm/Group Description

Blinded, active repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.

Blinded, sham repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.

 Total of all reporting groups
Overall Number of Baseline Participants 2 4 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 4 participants 6 participants
15  (1.41) 17.25  (1.5) 16.5  (1.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 6 participants
Female
2
 100.0%
3
  75.0%
5
  83.3%
Male
0
   0.0%
1
  25.0%
1
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 6 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
2
 100.0%
4
 100.0%
6
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 4 participants 6 participants
2 4 6
1.Primary Outcome
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated study. Data was not collected nor analyzed
Arm/Group Title Part 1 Active Part 1 Sham
Hide Arm/Group Description:

Blinded, active repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.

Blinded, sham repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated study. Data was not collected nor analyzed.
Arm/Group Title Part 1 Active Part 1 Sham
Hide Arm/Group Description:

Blinded, active repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.

Blinded, sham repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Mean Clinical Global Impression - Improvement (CGI-I) Score Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated study. Data was not collected nor analyzed.
Arm/Group Title Part 1 Active Part 1 Sham
Hide Arm/Group Description:

Blinded, active repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.

Blinded, sham repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events were collected from baseline to end of study, approximately 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part 1 Active Part 1 Sham
Hide Arm/Group Description

Blinded, active repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.

Blinded, sham repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS): 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.
All-Cause Mortality
Part 1 Active Part 1 Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Part 1 Active Part 1 Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      1/4 (25.00%)    
Psychiatric disorders     
Suicide attempt †  1/2 (50.00%)  1 1/4 (25.00%)  1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part 1 Active Part 1 Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      0/4 (0.00%)    
Nervous system disorders     
Headaches †  2/2 (100.00%)  15 0/4 (0.00%)  0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul E. Croarkin, D.O., M.S.
Organization: Mayo Clinic
Phone: 507-293-2557
EMail: Croarkin.Paul@mayo.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Paul E. Croarkin, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01804270    
Other Study ID Numbers: 12-003248 Part 1
First Submitted: March 1, 2013
First Posted: March 5, 2013
Results First Submitted: December 20, 2021
Results First Posted: January 19, 2022
Last Update Posted: January 19, 2022