Trial Outcomes & Findings for Antidepressant Mechanisms of Transcranial Magnetic Stimulation (NCT NCT02466230)

Last Updated: 2018-09-10

Results Overview

The Hamilton Depression Rating Scale is 24 items with total scores ranging from 0-76. Higher scores indicate greater severity of depression. (0-7 = None; 8-13 = Mild; 14-18 = Moderate; 19-23 = Severe; 23 and higher = very severe). Total scores are reported with no subscales.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

Change in score on Hamilton Depression Rating Scale from baseline to immediately after the final rTMS treatment (5 weeks)

Results posted on

2018-09-10

Participant Flow

Participant Flow of the Overall Study.

28 subjects were enrolled and all completed the study.

Participant milestones

Participant milestones
Measure	Active rTMS Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min. Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antidepressant Mechanisms of Transcranial Magnetic Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active rTMS n=28 Participants Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min. Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.
Age, Continuous	41.9 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	28 Participants n=5 Participants
Hamilton Depression Rating Scale	27.6 units on a scale STANDARD_DEVIATION 6.5 • n=5 Participants
Patient Health Questionnaire - 9 (PHQ-9)	14.3 units on a scale STANDARD_DEVIATION 8.4 • n=5 Participants

PRIMARY outcome

Timeframe: Change in score on Hamilton Depression Rating Scale from baseline to immediately after the final rTMS treatment (5 weeks)

Outcome measures

Outcome measures
Measure	Active rTMS n=28 Participants Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min. Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.
Depression Severity Measured by the Hamilton Depression Rating Scale (24-Item)	18.2 units on a scale Standard Deviation 7.7

SECONDARY outcome

Timeframe: Change in score in Public Health Questionnaire-9 from baseline to immediately after the final rTMS treatment (5 weeks)

Population: All 28 subjects completed the study but two subjects did not complete the final PHQ-9 assessment.

Self-rated scale of symptoms of depression. Nine items with a maximum score of 27. Higher score means more severe depression (0-4 = None; 5-9 = Mild; 10-14 = Moderate; 15-19 = Severe; 20 and higher = Very Severe).

Outcome measures

Outcome measures
Measure	Active rTMS n=26 Participants Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min. Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.
Depression Severity Measured by the Public Health Questionnaire-9	9.7 units on a scale Standard Deviation 6.3

Adverse Events

Active rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marc Dubin, M.D.

Weill Cornell Medical College

Phone: (212) 746-5817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place