N/A N=16 Randomized Double-blind Treatment

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

Bi-polar II Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01909011 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcome: Primary: Change From Baseline in Mean Beck Depression Inventory (BDI) Score at Week 2 — -13.01; -3.76 units on a scale — p=0.016

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active CES (Device); Sham CES (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Medical Center
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Beck Depression Inventory (BDI) Score at Week 2	-13.01; -3.76	0.016 sig
SECONDARY Change From Baseline in Mean Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at Week 2	18.50; -1.50	0.05
SECONDARY Change From Baseline in Mean Clinical Global Impressions Illness Severity (CGI-S) Score at Week 2	-0.86; -0.11	0.066

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

Eligibility Criteria

Inclusion Criteria

Diagnosis of bipolar II disorder currently in a depressive episode (without psychotic features)
Pretreatment HRSD score of >/= 13 and 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01909011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.