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

NCT01909011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-12-24

Study results available
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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 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

Conditions

  • Bi-polar II Disorder

Interventions

DEVICE

Active CES

The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.

DEVICE

Sham CES

The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.

Sponsors & Collaborators

  • Beth Israel Medical Center

    lead OTHER

Principal Investigators

  • Igor Galynker, MD, PhD · Beth Israel Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01909011 on ClinicalTrials.gov