A Pilot Study of Cranial Electrotherapy Stimulation[CES] for Generalized Anxiety Disorder
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|ClinicalTrials.gov Identifier: NCT00539357|
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : August 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder||Device: Cranial electrotherapy stimulation (CES)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2005|
|Actual Study Completion Date :||March 2006|
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.
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.
Other Name: Alpha-Stim Stress Control System (SCS)
- The Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: at baseline and after 3 and 6 weeks of treatment ]
- the Clinical Global Impression Improvement CGI-I scale (beginning at week 2), the 17-item Hamilton Rating Scale for Depression, Patients Global Impressions-Improvement ande the Four-Dimensional Anxiety and Depression Scale [ Time Frame: baseline, and after 3 and 6 weeks of treatment ]
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): NCT00539357
|Principal Investigator:||Alexander Bystritsky, MD||University of California, Los Angeles|