Clinical trial NCT02846740: 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
Overall status: TERMINATED
Phase: NA
Conditions: Suicide
Depression
Anxiety
Insomnia
Agitation
Keywords: cranial electric stimulation
suicide
psychiatric inpatients
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the Modifiable Suicide Risk Factors (MSRF's) Global Score
timeFrame: Baseline, 22 months,
measure: Adverse Effects and Safety
timeFrame: Baseline, 22 months,
Secondary outcomes:
measure: Length of Stay
timeFrame: Baseline, 22 months,
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Nithin E Krishna, MD
role: PRINCIPAL_INVESTIGATOR
References: