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Trial Outcomes & Findings for The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety Among Homeless Adults (NCT NCT02732561)

NCT ID: NCT02732561

Last Updated: 2018-10-16

Results Overview

Hamilton Depression Rating Scale. The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression and as a guide to evaluate recovery (Hedlund, 1979). The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Assessment time is estimated at 20 minutes (Hamilton, 1960). Higher values represent a worse outcome. The HAM-D form lists 21 items, the scoring is based on the first 17.Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2, with a total score range of 0-50.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

4 weeks

Results posted on

2018-10-16

Participant Flow

Participant milestones

Participant milestones
Measure
Sham Device
Sham device Sham device: Sham device
Intervention
CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device
Overall Study
STARTED
5
5
Overall Study
COMPLETED
3
4
Overall Study
NOT COMPLETED
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Sham Device
Sham device Sham device: Sham device
Intervention
CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device
Overall Study
Lost to Follow-up
1
1
Overall Study
Withdrawal by Subject
1
0

Baseline Characteristics

The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety Among Homeless Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sham Device
n=5 Participants
Sham device Sham device: Sham device
Intervention
n=5 Participants
CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device
Total
n=10 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
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
3 Participants
n=7 Participants
7 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
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 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
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 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

PRIMARY outcome

Timeframe: 4 weeks

Population: Only includes matched pairs

Hamilton Depression Rating Scale. The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression and as a guide to evaluate recovery (Hedlund, 1979). The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Assessment time is estimated at 20 minutes (Hamilton, 1960). Higher values represent a worse outcome. The HAM-D form lists 21 items, the scoring is based on the first 17.Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2, with a total score range of 0-50.

Outcome measures

Outcome measures
Measure
Sham Device
n=3 Participants
Sham device Sham device: Sham device
Intervention
n=4 Participants
CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device
Depressive Symptoms
13.00 units on a scale
Interval 7.0 to 18.0
6.50 units on a scale
Interval 6.0 to 9.0

PRIMARY outcome

Timeframe: 4 weeks

Population: includes only matched pairs

Hamilton Anxiety Rating Scale. The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety (Hamilton, 1959; McDowell, Newell \& \& McDowell, 2006). The scale consists of 14 items designed to assess the severity of a patient's anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe (with a total score range of 0-56). All of these scores are used to compute an overarching score that indicates a person's anxiety severity (Vaccarino, 2008). A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure
Sham Device
n=3 Participants
Sham device Sham device: Sham device
Intervention
n=4 Participants
CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device
Anxiety
8.00 units on a scale
Interval 6.0 to 15.0
6.00 units on a scale
Interval 5.0 to 6.0

Adverse Events

Sham Device

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention

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

James Kimball, MD

Wake Forest Health Sciences

Phone: 1 (336) 716-9702

Results disclosure agreements

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