Trial Outcomes & Findings for Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients. (NCT NCT02846740)

Last Updated: 2019-12-26

Results Overview

Efficacy of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary efficacy outcome measure will be change in the modifiable suicide risk factors (MSRF's) as indicated by a summed global score from rating scales measuring the MSRFs that include Montgomery-Åsberg Depression Rating Scale (range very severe = 44; severe = 31; moderate = 25; mild = 15; \& recovered = 7), Hamilton Anxiety Rating Scale (range of 0-56, \<17 indicates mild severity, 18-24, moderate severity \& 25-30 severe). Both scales were summed, the full theoretical scale range is 0-116, with higher scores indicating a worse outcome. Due to short hospital stays, we were not able to use Agitated Behavior Scale and Pittsburgh Sleep Quality Index scale in a meaningful manner to include in our analysis, so we did not include that scale.

Recruitment status

TERMINATED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Baseline, 22 months,

Results posted on

2019-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	Adjunctive CES CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).	Sham Control CES For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Overall Study STARTED	15	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adjunctive CES n=15 Participants CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).	Sham Control CES n=15 Participants For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).	Total n=30 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	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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	33.87 years STANDARD_DEVIATION 2 • n=5 Participants	31.87 years STANDARD_DEVIATION 2.5 • n=7 Participants	32.87 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 22 months,

Population: Many patients were discharged within a few days of admission, some left in two days, which left us with just baseline and several missing scales.

Outcome measures

Outcome measures
Measure	Adjunctive CES n=15 Participants CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).	Sham Control CES n=15 Participants For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Change From Baseline in the Modifiable Suicide Risk Factors (MSRF's) Global Score	35.33 score on a scale Standard Deviation 1.02	36.5 score on a scale Standard Deviation 1.04

PRIMARY outcome

Timeframe: Baseline, 22 months,

Safety of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary safety outcome measure will be responses to an adverse effect assessment questionnaire (GASE questionnaire).

Outcome measures

Outcome measures
Measure	Adjunctive CES n=15 Participants CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).	Sham Control CES n=15 Participants For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Adverse Effects and Safety	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 22 months,

Population: This was a difficult analysis considering patients had different motives for staying versus discharge

Outcome measures

Outcome measures
Measure	Adjunctive CES n=15 Participants CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).	Sham Control CES n=15 Participants For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Length of Stay	11 Days Standard Deviation 0.5	12 Days Standard Deviation 0.8

Adverse Events

Adjunctive CES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Control CES

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

Nithin krishna

University of Maryland Baltimore

Phone: 4103286661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place