Trial Outcomes & Findings for TMS for Suicidal Crisis in Active Duty SMs (NCT NCT03014362)

Last Updated: 2022-09-28

Results Overview

The Beck Scale for Suicidal Ideation (SSI-T) is a 19-item clinician administered scale measuring current suicide ideation (SSI-C), suicide ideation at its worst point in the patient's life (SSI-W), and degree of hopelessness. The scale has been well validated. SSI-T scores range from 0-38, with higher scores indicating greater suicide risk.

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

Change over the active treatment course ie. the 3 days of active treatment

Results posted on

2022-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	TMSactive TMSactive	TMSsham TMSsham
Overall Study STARTED	59	61
Overall Study COMPLETED	41	51
Overall Study NOT COMPLETED	18	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TMS for Suicidal Crisis in Active Duty SMs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TMSactive n=59 Participants TMSactive	TMSsham n=61 Participants TMSsham	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	61 Participants n=7 Participants	120 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.3 years STANDARD_DEVIATION 6.9 • n=5 Participants	26.5 years STANDARD_DEVIATION 6.4 • n=7 Participants	27.4 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	42 Participants n=7 Participants	86 Participants n=5 Participants
Race/Ethnicity, Customized demographic · black	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized demographic · white	35 Participants n=5 Participants	39 Participants n=7 Participants	74 Participants n=5 Participants
Race/Ethnicity, Customized demographic · hispanic	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized demographic · other	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants	61 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: Change over the active treatment course ie. the 3 days of active treatment

Outcome measures

Outcome measures
Measure	TMS Active n=59 Participants Group receiving active treatment	TMSsham n=61 Participants group receiving sham treatment
Change in Suicidal Ideation (Acute)	0.12 score on a scale Standard Error 0.06	0.12 score on a scale Standard Error 0.06

Adverse Events

TMS Active

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

TMS Sham

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TMS Active n=59 participants at risk group receiving active treatment	TMS Sham n=61 participants at risk group receiving sham treatment
Psychiatric disorders suicidal ideation	3.4% 2/59 • Number of events 2 • 6 months	3.3% 2/61 • Number of events 2 • 6 months

Other adverse events

Other adverse events
Measure	TMS Active n=59 participants at risk group receiving active treatment	TMS Sham n=61 participants at risk group receiving sham treatment
Psychiatric disorders pain	30.5% 18/59 • Number of events 18 • 6 months	11.5% 7/61 • Number of events 7 • 6 months

Additional Information

Christopher E Hines, MD

Walter Reed National Military Medical Center

Phone: 301-319-8122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place