Trial Outcomes & Findings for Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults (NCT NCT01869374)

NCT ID: NCT01869374

Last Updated: 2020-09-03

Results Overview

The unabbreviated scale title is "Hamilton Rating Scale for Depression." As its title suggests, this is a clinical measure of major depressive disorder. The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome: 0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: baseline (pre-treatment) and post-treatment
• Results posted on: 2020-09-03

Participant Flow

Five-day washout from all anti-depressants and mood stabilizers.

Participant milestones

Measure	Magnetic Seizure Therapy (MST) MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.	RUL ECT Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Overall Study STARTED	9	9
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Magnetic Seizure Therapy (MST) n=9 Participants MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.	Right Unilateral ECT (RUL ECT) n=9 Participants Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=9 Participants	4 Participants n=9 Participants	9 Participants n=18 Participants
Age, Categorical >=65 years	4 Participants n=9 Participants	5 Participants n=9 Participants	9 Participants n=18 Participants
Age, Continuous	66.3 years n=9 Participants	65.3 years n=9 Participants	65.8 years n=18 Participants
Sex: Female, Male Female	6 Participants n=9 Participants	5 Participants n=9 Participants	11 Participants n=18 Participants
Sex: Female, Male Male	3 Participants n=9 Participants	4 Participants n=9 Participants	7 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	9 participants n=9 Participants	18 participants n=18 Participants

PRIMARY outcome

Timeframe: baseline (pre-treatment) and post-treatment

The unabbreviated scale title is "Hamilton Rating Scale for Depression." As its title suggests, this is a clinical measure of major depressive disorder.

The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome:

0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression

Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study.

Outcome measures

Measure	Magnetic Seizure Therapy (MST) n=9 Participants MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.	RUL ECT n=9 Participants Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Hamilton Rating Scale for Depression, 24-Item (HRSD-24)	22.625 units on a scale Interval 16.0 to 29.0	15.375 units on a scale Interval 2.0 to 25.0

Adverse Events

Magnetic Seizure Therapy (MST)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RUL ECT

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

Stefan Rowny, MD

New York State Psychiatric Institute

Phone: (646) 774-5417

Email: stefan.rowny@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place