Use of Alpha-Stim Cranial-electrotherapy Stimulation (CES) in the Treatment of Anxiety

Completed · Phase 4 · Has a placebo group

Conditions studied: Anxiety

In brief

Is CES effective in the treatment of anxiety when accounting for any comorbid conditions and or current treatments including medication and psychotherapy.

Key facts

Study ID

NCT01533415

Run by

Wyndhurst Counseling Center

People needed

115

Starts

2012-02-01

Expected to finish

2012-12-01

Last updated by the study team

2013-04-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is male or female outpatients age 18 to 65 years.
• The subject meets DSM-IV criteria for an anxiety disorder.
• Participants with comorbidity must carry an anxiety disorder as a primary diagnosis.
• 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 greater than 15 on the Beck Anxiety Inventory and a score greater than 45 on the Zung Self Report Anxiety Scale.

You may not qualify if…

• The subject meets DSM-IV criteria for an Axis I diagnosis (other than an Anxiety Disorder) as the primary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa).
• The subject is clinically judged by the investigator to be at risk for suicide or is acutely suicidal.
• The subject is clinically judged by the investigator to be at risk for homicide or is acutely homicidal.
• 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.
• Use of a pacemaker.
• The subject is pregnant, planning to become pregnant, or nursing. If a subject becomes pregnant, she will be discontinued immediately and followed appropriately.
• Current psychotherapeutic treatment except for treatment with Specific Reuptake Inhibitor (SSRIs) medications which include: Fluoxetine (Prozac), Paroxetine (Paxil), Sertraline (Zoloft), Luvox (Fluvoxamine), Citalopram. Potential subjects may remain on their medications provided that he or she has been on a stable dose prior to entering this study; the dose and type of medication 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

Where it is running

• Liberty Univeristy Student Care and Grad.Assist Office — Lynchburg, Virginia, United States
• Wyndhurst Counseling Center — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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