Trial Outcomes & Findings for Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder (NCT NCT01415154)

NCT ID: NCT01415154

Last Updated: 2025-03-04

Results Overview

Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: 12 month evaluation
• Results posted on: 2025-03-04

Participant Flow

18 patients did not continue to randomization A) 12 failed randomization criteria: Acute phase endpoint HAMD17 total score <15 and had more than 25% improvement in total score HAMD17 compared with baseline B) 2 Patients moved C) 2 patients had inadequate response during Acute Phase D) 1 patient refused to return E) 1 patient had an unrelated panic attack

Participant milestones

Measure	Scheduled Treatment Arm Following completion of the efficacy assessments at Week 6, One NeuroStar TMS session every four week and TMS reintroduction as needed for clinical deterioration.	Monthly Observational Follow up Arm Following completion of the efficacy assessments at Week 6, Office follow-up visit once every 4 week and TMS reintroduction as needed for clinical deterioration.
Overall Study STARTED	23	26
Overall Study COMPLETED	10	6
Overall Study NOT COMPLETED	13	20

Reasons for withdrawal

Measure	Scheduled Treatment Arm Following completion of the efficacy assessments at Week 6, One NeuroStar TMS session every four week and TMS reintroduction as needed for clinical deterioration.	Monthly Observational Follow up Arm Following completion of the efficacy assessments at Week 6, Office follow-up visit once every 4 week and TMS reintroduction as needed for clinical deterioration.
Overall Study Lack of Efficacy	4	5
Overall Study Withdrawal by Subject	7	8
Overall Study Lost to Follow-up	1	4
Overall Study Protocol Violation	0	1
Overall Study Satisfactory Response	0	1
Overall Study Adverse Event	1	1

Baseline Characteristics

Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

Baseline characteristics by cohort

Measure	Scheduled Treatment Arm n=23 Participants 3 Week TMS taper, clinical assessments and one NeuroStar TMS session every 4th week of block and TMS reintroduction as needed for clinical deterioration. NeuroStar TMS: NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.	Monthly Observational Follow up Arm n=26 Participants 3 Week TMS Taper, clinical assessments and office follow up every 4th week of block and NeuroStar TMS reintroduction as needed for clinical deterioration. NeuroStar TMS: NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.	Total n=49 Participants Total of all reporting groups
Age, Continuous	48.2 years STANDARD_DEVIATION 13.3 • n=5 Participants	49.0 years STANDARD_DEVIATION 9.8 • n=7 Participants	48.6 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 month evaluation

Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.

Outcome measures

Measure	Scheduled Treatment Arm n=23 Participants Following completion of the efficacy assessments at Week 6, One NeuroStar TMS session every four week and TMS reintroduction as needed for clinical deterioration. NeuroStar TMS: NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.	Monthly Observational Follow up Arm n=26 Participants Following completion of the efficacy assessments at Week 6, Office follow-up visit once every 4 week and TMS reintroduction as needed for clinical deterioration. NeuroStar TMS: NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.
Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 Month evaluation

Change in depressive symptomatology will be assessed across the duration of maintenance treatment using observer and self-administered efficacy measures.

Outcome measures

Measure	Scheduled Treatment Arm n=23 Participants Following completion of the efficacy assessments at Week 6, One NeuroStar TMS session every four week and TMS reintroduction as needed for clinical deterioration. NeuroStar TMS: NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.	Monthly Observational Follow up Arm n=26 Participants Following completion of the efficacy assessments at Week 6, Office follow-up visit once every 4 week and TMS reintroduction as needed for clinical deterioration. NeuroStar TMS: NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.
Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms.	103.5 days Standard Deviation 61.3	97.8 days Standard Deviation 59.1

Adverse Events

Scheduled Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Monthly Observational Follow up Arm

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

Director of Clinical Operations

Neuronetics

Phone: 16123067393

Email: steve.erickson@neurostar.com

Results disclosure agreements

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