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Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression (rTMS)

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ClinicalTrials.gov Identifier: NCT01115699
Recruitment Status : Terminated (Stopped due to funding constraints and recruitment was slower than was expected)
First Posted : May 4, 2010
Results First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Sponsor:
Collaborator:
Neuronetics
Information provided by (Responsible Party):
David Mrazek, Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Intervention Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Repetitive Transcranial Magnetic Stimulation
Hide Arm/Group Description All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Repetitive Transcranial Magnetic Stimulation
Hide Arm/Group Description All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  50.0%
>=65 years
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Change in Hamilton Rating Scale for Depression (HRS-D17)
Hide Description The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.
Time Frame baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was stopped early due to funding constraints and recruitment was slower than was expected.
Arm/Group Title Repetitive Transcranial Magnetic Stimulation
Hide Arm/Group Description:
All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)
Hide Description

The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16.

Screening test scoring ranges:

  • 0-5, No Depression Likely
  • 6-10, Possibly Mildly Depressed
  • 11-15, Moderate Depression
  • 16-20, Severe Depression
  • 21 or Over, Very Severe Depression
Time Frame baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was stopped early due to funding constraints and recruitment was slower than was expected.
Arm/Group Title Repetitive Transcranial Magnetic Stimulation
Hide Arm/Group Description:
All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Repetitive Transcranial Magnetic Stimulation
Hide Arm/Group Description All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
All-Cause Mortality
Repetitive Transcranial Magnetic Stimulation
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Repetitive Transcranial Magnetic Stimulation
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Repetitive Transcranial Magnetic Stimulation
Affected / at Risk (%)
Total   0/2 (0.00%) 
This study was stopped early due to funding constraints and recruitment was slower than was expected.
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: Michelle Skime, Supervisor - Senior Clinical Research Coordinator
Organization: Mayo Clinic
Phone: 507-255-0501
EMail: skime.michelle@mayo.edu
Layout table for additonal information
Responsible Party: David Mrazek, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01115699     History of Changes
Other Study ID Numbers: 10-000401
First Submitted: April 30, 2010
First Posted: May 4, 2010
Results First Submitted: October 23, 2013
Results First Posted: December 13, 2013
Last Update Posted: December 13, 2013