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

Primary Purpose

Suicide, Depression, Anxiety

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alpha-Stim®.
Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring cranial electric stimulation, suicide, psychiatric inpatients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subject must be a patient admitted voluntarily to the UMMC adult psychiatric inpatient services with suicidal thoughts / intent / plan or suicide attempt who also has MSRFs including anxiety, agitation, insomnia, and/or depression).
  2. Subject must be between the ages of 18 and 65 (inclusive). Both men and women will be included
  3. Subjects who are female must have a negative pregnancy test prior to enrolling in the study, and must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, or oral/hormonal contraception or abstinence, which is typically the case on the inpatient units.
  4. If a subject has a substance abuse disorder, they must also have another non-substance abuse psychiatric disorder as determined from the clinical history.
  5. Chronic medical conditions such as endocrine disease, hypertension, renal disease, must be stable.
  6. Subject must be capable of giving informed consent. Subject must provide written informed consent prior to study participation.
  7. Subject must be capable of doing active or sham CES treatments and completing all study requirements.

Exclusion Criteria:

  1. Subject has a significant medical disorder with acute symptoms which could impair reliable participation in the trial or affect their MSRFs.
  2. Subject is pregnant.
  3. Subject has had concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study.
  4. Subject has a clinical history of poor compliance or in the investigator's judgment participation in the study would be clinically contraindicated.
  5. Subject has current or past behavior that suggests to the investigator that his/her suicidal behavior is driven by secondary gain, i.e. expressing suicidal thoughts so that s/he can be admitted due to homelessness.

Sites / Locations

  • University of Maryland School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Adjunctive CES

Sham control CES

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in the Modifiable Suicide Risk Factors (MSRF's) Global Score
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.
Adverse Effects and Safety
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).

Secondary Outcome Measures

Length of Stay

Full Information

First Posted
July 22, 2016
Last Updated
December 12, 2019
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT02846740
Brief Title
Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients.
Official Title
Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
No finding at halfway point of the study
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
January 22, 2018 (Actual)
Study Completion Date
January 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot study aims to investigate whether a treatment called cranial electric stimulation or CES can decrease risk factors for suicide. The specific CES device we will use is called Alpha-Stim®. CES will be used in addition to usual treatment (medication and group therapy).
Detailed Description
Suicide is still a major issue in the United States and all around the world. There are many reasons for people attempting suicide and the major modifiable risk factors are depression, anxiety, insomnia, and agitation. The standard treatment for all suicidal patients includes medication, admission to a hospital and reducing the risk factors. Medications have potential side effects and concerns about the drug interactions. One of the biological treatment alternatives to medication is cranial electric stimulation. This technique uses a device to stimulate the brain through electrical current. Using an Alpha-Stim® device, current is applied to the brain using skin electrodes which can be easily clipped on to the earlobe. The amount of current used is very low and is 1/1000 th of the current used for electroconvulsive therapy (ECT) and 1/10 th to 1/20 th of the 1-2 milliamperes used with transcranial direct current stimulation (tDCS). Our goal is to examine the safety and efficacy of this device when used as an add-on or adjunctive treatment to the usual treatments during the inpatient stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Depression, Anxiety, Insomnia, Agitation
Keywords
cranial electric stimulation, suicide, psychiatric inpatients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjunctive CES
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham control CES
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Alpha-Stim®.
Intervention Description
cranial electrical stimulation
Intervention Type
Behavioral
Intervention Name(s)
Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
Intervention Description
A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Primary Outcome Measure Information:
Title
Change From Baseline in the Modifiable Suicide Risk Factors (MSRF's) Global Score
Description
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.
Time Frame
Baseline, 22 months,
Title
Adverse Effects and Safety
Description
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).
Time Frame
Baseline, 22 months,
Secondary Outcome Measure Information:
Title
Length of Stay
Time Frame
Baseline, 22 months,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject must be a patient admitted voluntarily to the UMMC adult psychiatric inpatient services with suicidal thoughts / intent / plan or suicide attempt who also has MSRFs including anxiety, agitation, insomnia, and/or depression). Subject must be between the ages of 18 and 65 (inclusive). Both men and women will be included Subjects who are female must have a negative pregnancy test prior to enrolling in the study, and must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, or oral/hormonal contraception or abstinence, which is typically the case on the inpatient units. If a subject has a substance abuse disorder, they must also have another non-substance abuse psychiatric disorder as determined from the clinical history. Chronic medical conditions such as endocrine disease, hypertension, renal disease, must be stable. Subject must be capable of giving informed consent. Subject must provide written informed consent prior to study participation. Subject must be capable of doing active or sham CES treatments and completing all study requirements. Exclusion Criteria: Subject has a significant medical disorder with acute symptoms which could impair reliable participation in the trial or affect their MSRFs. Subject is pregnant. Subject has had concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study. Subject has a clinical history of poor compliance or in the investigator's judgment participation in the study would be clinically contraindicated. Subject has current or past behavior that suggests to the investigator that his/her suicidal behavior is driven by secondary gain, i.e. expressing suicidal thoughts so that s/he can be admitted due to homelessness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nithin E Krishna, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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