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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Suicide, Depression, Anxiety, Insomnia, Agitation

In brief

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).

Key facts

Study ID

NCT02846740

Run by

University of Maryland, Baltimore

People needed

30

Starts

2017-03-01

Expected to finish

2018-01-22

Last updated by the study team

2019-12-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Maryland School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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