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A Pilot Study of Cranial Electrotherapy Stimulation[CES] for Generalized Anxiety Disorder

NCT00539357 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-08-08

No results posted yet for this study

Summary

Cranial electrotherapy stimulation(CES) is a noninvasive procedure that has been used for decades in the United States to treat anxiety, depression, and insomnia in the general population. Whether CES is an effective treatment for patients with a DSM-IV diagnosis of generalized anxiety disorder (GAD) has not previously been explored. The goal of this study was is to evaluate the efficacy of CES in alleviating anxiety in patients with DSMIV-diagnosed GAD. Specifically our hypothesis was that CES would demonstrate possible efficacy in reducing symptoms associated with GAD from baseline to end of trial, as determined by: (1) change from baseline in the Hamilton Anxiety Scale (HAM-A) total score. a.) the proportion of responders (much or very much improved) as assessed by the CGI Improvement ratings by visit b.) the proportion of responders (50% reduction from total HAM A baseline score) according to the HAM A scores by visit c.) the proportion of patients in remission (HAM A score ≤7) by visit

Conditions

  • Generalized Anxiety Disorder

Interventions

DEVICE

Cranial electrotherapy stimulation (CES)

Cranial electrotherapy stimulation (CES) is a noninvasive procedure that involves applying a pulsed, low-amplitude electrical current to the head using electrodes placed on the earlobes. Cranial electrotherapy stimulation CES received U.S. Food and Drug Administration (FDA) approval for the treatment of insomnia, depression, and anxiety in 1979.

Sponsors & Collaborators

Principal Investigators

  • Alexander Bystritsky, MD · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-08-31
Completion
2006-03-31

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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 NCT00539357 on ClinicalTrials.gov