Status:
COMPLETED
A Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder
Lead Sponsor:
Beth Israel Medical Center
Conditions:
Bi-polar II Disorder
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the antidepressant effects of Cranial Electrotherapy Stimulation (CES) in the depressed phase of bipolar II disorder.; to examine the safety of daily CES in bipo...
Detailed Description
I. ABSTRACT Cranial electrical stimulation (CES) is a non-invasive brain stimulation technology that uses a small alternating current (1-2mA) applied to the scalp to affect brain function. The streng...
Eligibility Criteria
Inclusion
- Diagnosis of bipolar II disorder currently in a depressive episode (without psychotic features)
- Pretreatment HRSD score of \>/= 13 and \<28 and a CGI less than or equal to 5.
- Between 18 and 85 years old
- Willing to provide informed consent -
Exclusion
- Subject has a history of bipolar II disorder previously untreated with medication, or bipolar I disorder, or is in a manic or mixed episode; unipolar depression, schizophrenia, schizo-affective disorder, other (non mood disorder) psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), psychotic features in this or previous episodes, amnestic disorder, dementia or MMS (mini mental exam) less than or equal to 24, delirium. HRSD score \> 28 and CGI \> 5.
- Significant current history of autoimmune, endocrine, disorder affecting the brain. No unstable cardiac disease, uncontrolled hypertension or sleep apnea.
- Changes in psychotropic medications for 2 weeks prior to study entry amd unable to maintain stable doses throughout the trial.
- Subject has active suicide plan, or history of suicide attempt within the past 12 months.
- Pregnancy or positive serum pregnancy test.
- Having a pacemaker
- History of: skull fracture, craniotomy, deep brain stimulation, cochlear implants, dorsal column pacemaker, cardiac pacemaker, seizures or epilepsy.
- \-
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01909011
Start Date
January 1 2013
End Date
May 1 2014
Last Update
December 24 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Medical Center
New York, New York, United States, 10003