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

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.

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.