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

NCT00539357 | Completed Phase 4 DMC

• 1 other identifier: 04-08-121-02
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cranial Electrostimulation Therapy

Outcome Measures

Primary Outcomes (1)

• The Hamilton Anxiety Rating Scale (HAM-A)

  at baseline and after 3 and 6 weeks of treatment

Secondary Outcomes (1)

• 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

  baseline, and after 3 and 6 weeks of treatment

Study Arms (1)

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.

Device: Cranial electrotherapy stimulation (CES)

Interventions

Cranial electrotherapy stimulation (CES) DEVICE

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.

Also known as: Alpha-Stim Stress Control System (SCS)

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is male or female outpatients age 18 to 65 years, inclusive
• The subject meets DSM-IV criteria for Generalized Anxiety Disorder as determined by the MINI
• 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.
• Written informed consent must be obtained from the subject prior to study participation.
• The subject is in good medical health or with chronic medical conditions which are currently stable.
• No current abuse of alcohol or other substance.
• The subject has a total score of 20 or more on the Hamilton Anxiety Scale (HAMA) at screening.
• The subject has a Clinical Global Impression (CGI) Severity score of 4 or more at screening.

You may not qualify if:

• 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.
• 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.
• 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.
• The subject has a psychiatric condition that would require inpatient, or partial psychiatric hospitalization.
• Seizure disorders.
• 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.
• The subject is pregnant, planning to become pregnant, or nursing. If a subject becomes pregnant, she will be discontinued immediately and followed appropriately.
• Concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study.
• 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.
• History of poor compliance or in the Investigator's judgment patients any subject whose treatment as an outpatient would be clinically contraindicated
• The subject has attempted suicide one or more times within the past twelve months
• The subject has a Hamilton Depression Rating Scale (HAM-D) score above 38 which suggests a moderate to severe clinical level of depressive symptoms

Sponsors & Collaborators

• University of California, Los Angeles: lead

Related Publications (3)

• Bystritsky A, Kerwin LE, Feusner JD. A preliminary study of fMRI-guided rTMS in the treatment of generalized anxiety disorder: 6-month follow-up. J Clin Psychiatry. 2009 Mar;70(3):431-2. doi: 10.4088/JCP.08l04641. No abstract available.

  PMID: 19317960 DERIVED

• Bystritsky A, Kaplan JT, Feusner JD, Kerwin LE, Wadekar M, Burock M, Wu AD, Iacoboni M. A preliminary study of fMRI-guided rTMS in the treatment of generalized anxiety disorder. J Clin Psychiatry. 2008 Jul;69(7):1092-8. doi: 10.4088/jcp.v69n0708.

  PMID: 18572984 DERIVED

• Bystritsky A, Kerwin L, Feusner J. A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder. J Clin Psychiatry. 2008 Mar;69(3):412-7. doi: 10.4088/jcp.v69n0311.

  PMID: 18348596 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Alexander Bystritsky, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 4, 2007
• Study Start: August 1, 2005
• Study Completion: March 1, 2006
• Last Updated: August 8, 2016

Record last verified: 2016-08