A Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder

Completed · Not applicable · Has a placebo group

Conditions studied: Bi-polar II Disorder

In brief

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 bipolar II patients; and to examine the effects of 20 minutes of daily CES on EEG reading. The investigators hypothesize: 1. The CES will reduce symptom severity more than sham (placebo) CES. 2. That CES administered for 20 minutes daily for four weeks is safe and well tolerated when treating bipolar II patients. 3. That CES will shift the alpha and beta power fractions of EEG downward, and that this shift correlates with a decrease in level of anxiety and depression

Key facts

Study ID

NCT01909011

Run by

Beth Israel Medical Center

People needed

16

Starts

2013-01-01

Expected to finish

2014-05-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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.

Where it is running

• Beth Israel Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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