Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients.
NCT ID: NCT02846740
Last Updated: 2019-12-26
Study Results
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View full resultsBasic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2017-03-01
2018-01-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Adjunctive CES
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.
Alpha-Stim®.
cranial electrical stimulation
Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Sham control CES
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.
Alpha-Stim®.
cranial electrical stimulation
Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Interventions
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Alpha-Stim®.
cranial electrical stimulation
Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Nithin Krishna
Assistant Professor of Psychiatry
Principal Investigators
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Nithin E Krishna, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
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University of Maryland School of Medicine
Baltimore, Maryland, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Document Type: Study Protocol
Other Identifiers
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HP-00065640
Identifier Type: -
Identifier Source: org_study_id