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Sponsored by: |
University of California, Los Angeles |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00539357 |
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
Condition | Intervention | Phase |
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Generalized Anxiety Disorder |
Device: Cranial electrotherapy stimulation (CES) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Enrollment: | 12 |
Study Start Date: | August 2005 |
Study Completion Date: | March 2006 |
Arms | Assigned Interventions |
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1: Experimental
All patients self-administered stimulation for 60 consecutive minutes each day. Participants self-administered the treatment for a period of 6 weeks, 7 days a week between the hours of 15:00 and 19:00. Assessments took place every 2 weeks during the treatment period.
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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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 04-08-121-02 |
Study First Received: | October 2, 2007 |
Last Updated: | October 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00539357 |
Health Authority: | United States: Institutional Review Board |
Cranial Electrostimulation Therapy |
Anxiety Disorders Mental Disorders |
Pathologic Processes Disease |