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

NCT01909011 | Completed Results

• 1 other identifier: #199-11
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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. 1.The CES will reduce symptom severity more than sham (placebo) CES.
2. 2.That CES administered for 20 minutes daily for four weeks is safe and well tolerated when treating bipolar II patients.
3. 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Beck Depression Inventory (BDI) Score at 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).

  Baseline to Week 2

Secondary Outcomes (2)

• Change From Baseline in Mean Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at Week 2

  Baseline to Week 2

• Change From Baseline in Mean Clinical Global Impressions Illness Severity (CGI-S) Score at Week 2

  Baseline to Week 2

Study Arms (2)

Active CES

EXPERIMENTAL

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

Sham CES

SHAM COMPARATOR

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

Device: Sham CES

Interventions

Active CES DEVICE

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.

Also known as: FW-100 Fisher Wallace Stimulator

Active CES

Sham CES DEVICE

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

Also known as: FW-100 Fisher Wallace Stimulator

Sham CES

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Related Publications (1)

• McClure D, Greenman SC, Koppolu SS, Varvara M, Yaseen ZS, Galynker II. A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression. J Nerv Ment Dis. 2015 Nov;203(11):827-35. doi: 10.1097/NMD.0000000000000378.

  PMID: 26414234 DERIVED

Limitations and Caveats

* A small sample size. * A possible self-selection bias due to extensive time commitment required from the study participants.

Results Point of Contact

• Title: Igor Galynker MD PhD
• Organization: Mount Sinai Beth Israel

igalynke@chpnet.org

212-420-4535

Study Officials

• Igor Galynker, MD, PhD

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 26, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 24, 2015
• Results First Posted: December 24, 2015

Record last verified: 2015-02

Locations

US (1)