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

This study has been completed.
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00539357
First received: October 2, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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
Generalized Anxiety Disorder
Device: Cranial electrotherapy stimulation (CES)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • The Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: at baseline and after 3 and 6 weeks of treatment ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: August 2005
Study Completion Date: March 2006
Arms Assigned Interventions
Experimental: 1
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is male or female outpatients age 18 to 65 years, inclusive
  2. The subject meets DSM-IV criteria for Generalized Anxiety Disorder as determined by the MINI
  3. Sexually active female patients of childbearing potential must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception or abstinence. Female patients of childbearing potential must have a negative pregnancy test prior to receiving study drug.
  4. Written informed consent must be obtained from the subject prior to study participation.
  5. The subject is in good medical health or with chronic medical conditions which are currently stable.
  6. No current abuse of alcohol or other substance.
  7. The subject has a total score of 20 or more on the Hamilton Anxiety Scale (HAMA) at screening.
  8. The subject has a Clinical Global Impression (CGI) Severity score of 4 or more at screening.

Exclusion Criteria:

  1. The subject meets DSM-IV criteria for an Axis I diagnosis (other than GAD) as the primary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) as determined by the MINI.
  2. The subject is clinically judged by the investigator to be at risk for suicide or is acutely suicidal as objectively measured by the MINI and MSE.
  3. The subject is clinically judged by the investigator to be at risk for homicide or is acutely homicidal as objectively measured by the MINI and MSE.
  4. The subject has a psychiatric condition that would require inpatient, or partial psychiatric hospitalization.
  5. Seizure disorders.
  6. Significant history of medical disease (i.e. cardiovascular, hepatic (e.g. cirrhosis, hepatitis B or C) renal, gynecological, musculoskeletal, neurological, gastrointestinal, metabolic, hematological, endocrine, cancer with a metastatic potential or progressive neurological disorders) which could impair reliable participation in the trial or necessitate the use of medication not allowed by this protocol.
  7. The subject is pregnant, planning to become pregnant, or nursing. If a subject becomes pregnant, she will be discontinued immediately and followed appropriately.
  8. Concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study.
  9. Current psychotherapeutic treatment except for treatment with Specific Reuptake Inhibitor (SSRIs) medications which include: Fluoxetine (Prozac), Paroxetine (Paxil), Sertraline (Zoloft), Luvox (Fluvoxamine), and Citalopram. Potential subjects may remain on one of the SSRI medications provided that he or she has been on a stable dose for at least 4 weeks prior to entering this study; this dose remains stable throughout the remainder of this study; and it can be determined that this medication is not exacerbating the anxiety symptoms.
  10. History of poor compliance or in the Investigator's judgment patients any subject whose treatment as an outpatient would be clinically contraindicated
  11. The subject has attempted suicide one or more times within the past twelve months
  12. The subject has a Hamilton Depression Rating Scale (HAM-D) score above 38 which suggests a moderate to severe clinical level of depressive symptoms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539357

Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Alexander Bystritsky, MD University of California, Los Angeles
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00539357     History of Changes
Other Study ID Numbers: 04-08-121-02
Study First Received: October 2, 2007
Last Updated: October 2, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Cranial Electrostimulation Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014