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

NCT02846740 | Terminated Results DMC FDA Device

• 1 other identifier: HP-00065640
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Suicide; Depression; Anxiety; Insomnia; Agitation

Keywords

cranial electric stimulation; suicide; psychiatric inpatients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Length of Stay

  Baseline, 22 months,

Study Arms (2)

Adjunctive CES

EXPERIMENTAL

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®.; Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale

Sham control CES

SHAM COMPARATOR

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®.; Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale

Interventions

Alpha-Stim®. DEVICE

cranial electrical stimulation

Adjunctive CES; Sham control CES

Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale BEHAVIORAL

A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).

Adjunctive CES; Sham control CES

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Suicide; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia

Results Point of Contact

• Title: Nithin krishna
• Organization: University of Maryland Baltimore

nkrishna@som.umaryland.edu

4103286661

Study Officials

• Nithin E Krishna, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 27, 2016
• Study Start: March 1, 2017
• Primary Completion: January 22, 2018
• Study Completion: January 22, 2018
• Last Updated: December 26, 2019
• Results First Posted: December 26, 2019

Record last verified: 2019-12

Locations

US (1)