CES for Generalized Anxiety Disorder

N/A

Recruiting

Led By Samantha Meltzer-Brody, MD

Research Sponsored by Electromedical Products International, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stated willingness to comply with all study procedures and availability for the duration of the study including refraining from changes to treatment unless medically indicated and communicated to the study team

Diagnosis of generalized anxiety disorder (GAD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days

Summary

This trial studies how a gentle electric current to the head may reduce anxiety in 18-21y/o w/ generalized anxiety disorder.

Who is the study for?

This trial is for young adults aged 18-21 with Generalized Anxiety Disorder (GAD). Participants must be able to consent, follow the study's procedures, and use effective contraception if applicable. They should have mild-to-moderate anxiety symptoms and either maintain a stable dose of current psychiatric meds or not change their treatment during the study.

What is being tested?

The trial is testing cranial electrotherapy stimulation (CES) as an at-home treatment for reducing anxiety symptoms in individuals with GAD. It aims to understand how CES affects this age group when administered outside of a clinical setting.

What are the potential side effects?

While specific side effects are not listed here, CES generally may cause mild headaches, dizziness, or skin irritation at the electrode sites. Most people tolerate it well without serious adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to follow the study rules and be available for its duration without changing my treatment unless it's medically necessary.

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I have been diagnosed with generalized anxiety disorder.

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My anxiety symptoms are at least mild to moderate.

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I am between 18 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Beck Anxiety Inventory (BAI) Change

Change in Clinical Global Impression Scale (CGI)

Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cranial Electrotherapy Stimulation (CES)Experimental Treatment1 Intervention

Alpha-Stim AID ® is an FDA-cleared device for the treatment of anxiety that delivers CES through two earclip electrodes.

Group II: Sham Cranial Electrotherapy Stimulation (CES)Placebo Group1 Intervention

The device for sham stimulation is physically identical and delivers a non-therapeutic dose of stimulation to replicate salient features of device usage.

0 / 4Eligibility criteria met