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

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ClinicalTrials.gov Identifier: NCT01909011
Recruitment Status : Completed
First Posted : July 26, 2013
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center

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 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

Condition or disease Intervention/treatment Phase
Bi-polar II Disorder Device: Active CES Device: Sham CES Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Blind, Randomized, Sham Controlled Study of Cranial Electrical Stimulation in Bipolar II Disorder
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: 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: 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.
Other Name: FW-100 Fisher Wallace Stimulator

Sham Comparator: Sham CES
The CES sham group will receive sham CES (device off)for 20 minutes 5 times per week for two weeks.
Device: Sham CES
The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.
Other Name: FW-100 Fisher Wallace Stimulator




Primary Outcome Measures :
  1. Change From Baseline in Mean Beck Depression Inventory (BDI) Score at Week 2 [ Time Frame: Baseline to Week 2 ]
    BDI is a validated, self-report measure used to assess the level of depression symptom severity. BDI values range from 0 (normal) to 63 (extreme depression). Mean Change = (Week 2 Mean Score - Baseline Mean Score).


Secondary Outcome Measures :
  1. Change From Baseline in Mean Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at Week 2 [ Time Frame: Baseline to Week 2 ]
    Q-LES-Q is a validated 16-item self-report measure of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning such as physical well-being, work, home, social relationships and leisure activities. Each item is rated on a 1 - 5 point scale. Q-LES-Q values range from 0 (very low quality of life) to 100 (high quality of life). Mean Change = (Week 2 Mean Score - Baseline Mean Score).

  2. Change From Baseline in Mean Clinical Global Impressions Illness Severity (CGI-S) Score at Week 2 [ Time Frame: Baseline to Week 2 ]
    CGI-S instrument measures the level of severity of illness rated by a qualified clinician. CGI-S values range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). Mean Change = (Week 2 Mean Score - Baseline Mean Score).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of bipolar II disorder currently in a depressive episode (without psychotic features)
  2. Pretreatment HRSD score of >/= 13 and <28 and a CGI less than or equal to 5.
  3. Between 18 and 85 years old
  4. Willing to provide informed consent -

Exclusion Criteria:

  1. 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.
  2. Significant current history of autoimmune, endocrine, disorder affecting the brain. No unstable cardiac disease, uncontrolled hypertension or sleep apnea.
  3. Changes in psychotropic medications for 2 weeks prior to study entry amd unable to maintain stable doses throughout the trial.
  4. Subject has active suicide plan, or history of suicide attempt within the past 12 months.
  5. Pregnancy or positive serum pregnancy test.
  6. Having a pacemaker
  7. History of: skull fracture, craniotomy, deep brain stimulation, cochlear implants, dorsal column pacemaker, cardiac pacemaker, seizures or epilepsy.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909011


Locations
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United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
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Principal Investigator: Igor Galynker, MD, PhD Beth Israel Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01909011     History of Changes
Other Study ID Numbers: #199-11
First Posted: July 26, 2013    Key Record Dates
Results First Posted: December 24, 2015
Last Update Posted: December 24, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Disease
Pathologic Processes