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

Study Overview
=================
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.

Official Title
-----------------
Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients

Conditions
-----------------
Suicide, Depression, Anxiety, Insomnia, Agitation

Intervention / Treatment
-----------------
* Device: Alpha-Stim®.
* Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjunctive CES<br>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. | Device: Alpha-Stim®.<br>* cranial electrical stimulation<br>Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale<br>* A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).<br>|
| Sham Comparator: Sham control CES<br>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. | Device: Alpha-Stim®.<br>* cranial electrical stimulation<br>Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale<br>* A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 22 months, | 
| 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). | Baseline, 22 months, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay |  | Baseline, 22 months, | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cranial electric stimulation, suicide, psychiatric inpatients