Trial Outcomes & Findings for Transcranial Magnetic Stimulation for Adolescent Depression (NCT NCT01731678)

Results Overview

Response defined as: a reduction of Hamilton Depression Rating Scale score of 50% or more Name: Hamilton Depression Rating Scale Construct: Depression Range: 0-52 Direction: Higher is worse depression symptoms/severity Sub-scales: Not applicable. Reference: Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

Three weeks

Results posted on

2020-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Transcranial Magnetic Stimulation The standardized treatment location is the left DLPFC. Anatomical T1 images from the pre-intervention MRI were loaded into our neuronavigation software (Brainsight2, Rogue Research, Montreal). The coil was placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) consisted of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
Overall Study STARTED	39
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Transcranial Magnetic Stimulation The standardized treatment location is the left DLPFC. Anatomical T1 images from the pre-intervention MRI were loaded into our neuronavigation software (Brainsight2, Rogue Research, Montreal). The coil was placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) consisted of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
Overall Study Withdrawal by Subject	3
Overall Study Did not meet inclusion criteria	1
Overall Study RMT too high, making TMS difficult	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial Magnetic Stimulation n=32 Participants The standardized treatment location is the left DLPFC. Anatomical T1 images from the pre-intervention MRI were loaded into our neuronavigation software (Brainsight2, Rogue Research, Montreal). The coil was placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) consisted of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
Age, Continuous	17.57 Years STANDARD_DEVIATION 1.98 • n=32 Participants
Sex: Female, Male Female	15 Participants n=32 Participants
Sex: Female, Male Male	17 Participants n=32 Participants
Region of Enrollment Canada	32 participants n=32 Participants
Baseline Hamilton Depression Rating Scale Score	20.25 units on a scale STANDARD_DEVIATION 6.37 • n=32 Participants

PRIMARY outcome

Timeframe: Three weeks

Response defined as: a reduction of Hamilton Depression Rating Scale score of 50% or more Name: Hamilton Depression Rating Scale Construct: Depression Range: 0-52 Direction: Higher is worse depression symptoms/severity Sub-scales: Not applicable. Reference: Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96.

Outcome measures

Outcome measures
Measure	Transcranial Magnetic Stimulation n=32 Participants The standardized treatment location is the left DLPFC. Anatomical T1 images from the pre-intervention MRI were loaded into our neuronavigation software (Brainsight2, Rogue Research, Montreal). The coil was placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) consisted of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
Hamilton Depression Rating Scale	9.38 score on a scale Standard Deviation 5.44

OTHER_PRE_SPECIFIED outcome

Timeframe: After the first 10 patients are completed

There will be an interim analysis to review safety, tolerability (as measured by our rTMS tolerability scale) after the first 10 rTMS patients. Should there be significant concerns, the team will terminate the study. Ten was selected as it is close to previous reports and should be informative.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: After the first 10 patients are completed

There will be an interim analysis to review response (Ham-D) after the first 10 rTMS patients. Should there be significant concerns, the team will terminate the study. Ten was selected as it is close to previous reports and should be informative.

Outcome measures

Outcome data not reported

Adverse Events

Transcranial Magnetic Stimulation

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

Frank MacMaster, PI of the project

University of Calgary

Phone: 403-955-2784

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place