Trial Outcomes & Findings for Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression (NCT NCT01115699)
NCT ID: NCT01115699
Last Updated: 2013-12-13
Results Overview
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.
TERMINATED
NA
2 participants
baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
2013-12-13
Participant Flow
Participant milestones
| Measure |
Repetitive Transcranial Magnetic Stimulation
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.
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|---|---|
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Overall Study
STARTED
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2
|
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Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression
Baseline characteristics by cohort
| Measure |
Repetitive Transcranial Magnetic Stimulation
n=2 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeksPopulation: This study was stopped early due to funding constraints and recruitment was slower than was expected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeksPopulation: This study was stopped early due to funding constraints and recruitment was slower than was expected.
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
Outcome measures
Outcome data not reported
Adverse Events
Repetitive Transcranial Magnetic Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michelle Skime, Supervisor - Senior Clinical Research Coordinator
Mayo Clinic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place