Generalized Anxiety DisorderNCT06124014
CES for the Treatment of GAD in Young Adults
A study testing At-Home Stimulation in people with Generalized Anxiety Disorder, run by Electromedical Products International, Inc. at 1 site in United States.
Trial summary
The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age. Read more about this study
- Who is it for?
- Ages 18 to 21 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- At-Home Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Capable of signing informed consent form.
- 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.
- Aged 18 - 21 at time of screening visit.
- Diagnosis of generalized anxiety disorder (GAD).
- At least mild-to-moderate symptom severity, as indicated by scores of 15 or higher on the clinician-administered HAM-A at the screening visit.
- Concurrent psychiatric medications are allowed. Participants will be required to maintain a sable dose of medications, or remain medication free, for 2 weeks prior to the screening visit, except for antidepressants for which the period of stable dose is 4 weeks prior to screening visit. Concurrent psychotherapy is allowed.
- People of reproductive potential must be willing to use effective contraception (evidence-based hormonal or barrier methods) for at least 1 month prior to the screening visit and agree to use such a method during study participation.
Who cannot join
- Time-frames are determined relative to the screening visit.
- Current (any) or previous (> 7 stimulation sessions in last 6 weeks) use of a CES device.
- Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.
- Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or within 60 days prior to screening visit).
- Implanted medical device that uses electricity anywhere in the body.
- Diagnosis (based on MINI) of bipolar I or II (past or current), moderate or severe alcohol use disorder (within 12 months prior to screening visit), moderate or severe (non-alcohol) substance use disorder (within 12 months prior to screening visit), psychotic disorder (current or lifetime), major depressive disorder with psychotic features, bipolar I with psychotic features, anorexia nervosa.
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- Epilepsy (current or history). History of febrile childhood seizures and non-epileptic seizures are allowed.
- Pregnant or breast-feeding.
- Enrollment in clinical trial for any condition (current or within 60 days prior to screening visit).
- Hospitalization for any reason (current or past 2 weeks).
- Self-harming behaviors (current or within two years prior to screening visit).
- Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS).
- Known cardiac abnormality or clinically significant heart disease.
- Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, 27516
About this study
Official title: Cranial Electrotherapy Stimulation (CES) for the Treatment of Generalized Anxiety Disorder (GAD) in Young Adults: Double-Blind Sham-Controlled Randomized Clinical Trial
The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age.
Read the detailed description
This study examines (1) the efficacy of CES with the Alpha-Stim AID ® for the treatment of GAD in young adults (18-21 years of age) in a double-blind, sham-controlled parallel group single-site clinical trial of 130 participants.
Participants will be randomized into receiving either active CES (at least 200uA, up to 500uA at 0.5Hz, 60 minutes daily for six weeks) or sham CES with the Alpha-Stim AID ® device at-home. Clinical assessments of anxiety symptoms are performed at Screening (for eligibility), Baseline, Follow-Up 1 (at completion of intervention, 6 weeks after initial stimulation), and Follow-Up 2 (12 weeks after initial stimulation). Additional assessments of depression symptoms and quality of life are included. Resting-state EEG will be collected at baseline and Follow-Up 1 (in up to 60 participants) for exploratory investigation of mechanism of action.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- At-Home Stimulation
- Keywords
- CES
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-Home StimulationDevice
The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cranial Electrotherapy Stimulation (CES) | Experimental | Alpha-Stim AID ® is an FDA-cleared device for the treatment of anxiety that delivers CES through two earclip electrodes. Receives: Device: At-Home Stimulation |
| Sham Cranial Electrotherapy Stimulation (CES) | Sham comparator | The device for sham stimulation is physically identical and delivers a non-therapeutic dose of stimulation to replicate salient features of device usage. Receives: Device: At-Home Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale (HAM-A) change
Change in HAM-A between six-week follow-up (FU1) and baseline (D1); minimum value is 0, maximum value is 56. Higher scores indicate worse outcome.
Measured: 42 days
Secondary outcomes (11)
Hamilton Anxiety Rating Scale (HAM-A) change
Change in HAM-A between twelve-week follow-up (FU2) and D1; minimum value is 0, maximum value is 56. Higher scores indicate worse outcome.
Measured: 84 days
Beck Anxiety Inventory (BAI) Change
Change in BAI between FU1 and D1; minimum value is 0, maximum value is 63. Higher scores indicate worse outcome.
Measured: 42 days
Beck Anxiety Inventory (BAI) Change
Change in BAI between FU2 and D1; minimum value is 0, maximum value is 63. Higher scores indicate worse outcome.
Measured: 84 days
Generalized-Anxiety Disorder 7-item (GAD-7) Change
Change in GAD-7 between FU1 and D1; minimum value is 0, maximum value is 21. Higher scores indicate worse outcome.
Measured: 42 days
Generalized-Anxiety Disorder 7-item (GAD-7) Change
Change in GAD-7 between FU2 and baseline D1; minimum value is 0, maximum value is 21. Higher scores indicate worse outcome.
Measured: 84 days
Response/Remission of anxiety
Response/remission rates based on HAM-A scores from FU1 versus baseline D1
Measured: 42 days
Response/Remission of anxiety
Response/remission rates based on HAM-A scores from FU2 versus baseline D1
Measured: 84 days
Change in Clinical Global Impression Scale (CGI)
Change in CGI from FU1 to D1; CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.
Measured: 42 days
Change in Clinical Global Impression Scale (CGI)
Change in CGI from FU2 to baseline D1; CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.
Measured: 84 days
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
Change in Q-LES-Q-SF from FU1 to D1; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.
Measured: 42 days
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
Change in Q-LES-Q-SF from FU2 to D1; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start26 Jan 2024
- Primary completion17 Dec 2025
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Electromedical Products International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Samantha Meltzer-Brody, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124014
- Sponsor's protocol ID
- 22-3341
- Status last verified
- Feb 2025
- First submitted
- 20 Oct 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. 2014 Aug;164:171-7. doi: 10.1016/j.jad.2014.04.029. Epub 2014 Apr 21.
PubMed 24856571Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow.
PubMed 26487813Goodwin RD, Weinberger AH, Kim JH, Wu M, Galea S. Trends in anxiety among adults in the United States, 2008-2018: Rapid increases among young adults. J Psychiatr Res. 2020 Nov;130:441-446. doi: 10.1016/j.jpsychires.2020.08.014. Epub 2020 Aug 21.
PubMed 32905958Hajek A, Sabat I, Neumann-Bohme S, Schreyogg J, Barros PP, Stargardt T, Konig HH. Prevalence and determinants of probable depression and anxiety during the COVID-19 pandemic in seven countries: Longitudinal evidence from the European COvid Survey (ECOS). J Affect Disord. 2022 Feb 15;299:517-524. doi: 10.1016/j.jad.2021.12.029. Epub 2021 Dec 15.
PubMed 34920039Garakani A, Murrough JW, Freire RC, Thom RP, Larkin K, Buono FD, Iosifescu DV. Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options. Front Psychiatry. 2020 Dec 23;11:595584. doi: 10.3389/fpsyt.2020.595584. eCollection 2020.
PubMed 33424664
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Electrotherapy Stimulation (CES) for the Treatment of Generalized Anxiety Disorder (GAD) in Young Adults: Double-Blind Sham-Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06124014
- Acronym / sponsor ID
- 22-3341
- Conditions
- Generalized Anxiety Disorder
- Keywords
- CES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Electromedical Products International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age.
Detailed description
This study examines (1) the efficacy of CES with the Alpha-Stim AID ® for the treatment of GAD in young adults (18-21 years of age) in a double-blind, sham-controlled parallel group single-site clinical trial of 130 participants.
Participants will be randomized into receiving either active CES (at least 200uA, up to 500uA at 0.5Hz, 60 minutes daily for six weeks) or sham CES with the Alpha-Stim AID ® device at-home. Clinical assessments of anxiety symptoms are performed at Screening (for eligibility), Baseline, Follow-Up 1 (at completion of intervention, 6 weeks after initial stimulation), and Follow-Up 2 (12 weeks after initial stimulation). Additional assessments of depression symptoms and quality of life are included. Resting-state EEG will be collected at baseline and Follow-Up 1 (in up to 60 participants) for exploratory investigation of mechanism of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranial Electrotherapy Stimulation (CES) | Experimental | Device: At-Home StimulationAlpha-Stim AID ® is an FDA-cleared device for the treatment of anxiety that delivers CES through two earclip electrodes. |
| Sham Cranial Electrotherapy Stimulation (CES) | Sham comparator | Device: At-Home StimulationThe device for sham stimulation is physically identical and delivers a non-therapeutic dose of stimulation to replicate salient features of device usage. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Capable of signing informed consent form.
- 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.
- Aged 18 - 21 at time of screening visit.
- Diagnosis of generalized anxiety disorder (GAD).
- At least mild-to-moderate symptom severity, as indicated by scores of 15 or higher on the clinician-administered HAM-A at the screening visit.
Key exclusion criteria (14 listed)
- Time-frames are determined relative to the screening visit.
- Current (any) or previous (> 7 stimulation sessions in last 6 weeks) use of a CES device.
- Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.
- Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or within 60 days prior to screening visit).
- Implanted medical device that uses electricity anywhere in the body.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At-Home StimulationThe stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions. | Device | Cranial Electrotherapy Stimulation (CES), Sham Cranial Electrotherapy Stimulation (CES) |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A) change
Time frame: 42 days
Change in HAM-A between six-week follow-up (FU1) and baseline (D1); minimum value is 0, maximum value is 56. Higher scores indicate worse outcome.
11 secondary outcomes
Hamilton Anxiety Rating Scale (HAM-A) change
Time frame: 84 days
Beck Anxiety Inventory (BAI) Change
Time frame: 42 days
Beck Anxiety Inventory (BAI) Change
Time frame: 84 days
Generalized-Anxiety Disorder 7-item (GAD-7) Change
Time frame: 42 days
Generalized-Anxiety Disorder 7-item (GAD-7) Change
Time frame: 84 days
Response/Remission of anxiety
Time frame: 42 days
Response/Remission of anxiety
Time frame: 84 days
Change in Clinical Global Impression Scale (CGI)
Time frame: 42 days
Change in Clinical Global Impression Scale (CGI)
Time frame: 84 days
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
Time frame: 42 days
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 24856571Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. 2014 Aug;164:171-7. doi: 10.1016/j.jad.2014.04.029. Epub 2014 Apr 21.
- Background: PubMed 26487813Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow.
- Background: PubMed 32905958Goodwin RD, Weinberger AH, Kim JH, Wu M, Galea S. Trends in anxiety among adults in the United States, 2008-2018: Rapid increases among young adults. J Psychiatr Res. 2020 Nov;130:441-446. doi: 10.1016/j.jpsychires.2020.08.014. Epub 2020 Aug 21.
- Background: PubMed 34920039Hajek A, Sabat I, Neumann-Bohme S, Schreyogg J, Barros PP, Stargardt T, Konig HH. Prevalence and determinants of probable depression and anxiety during the COVID-19 pandemic in seven countries: Longitudinal evidence from the European COvid Survey (ECOS). J Affect Disord. 2022 Feb 15;299:517-524. doi: 10.1016/j.jad.2021.12.029. Epub 2021 Dec 15.
- Background: PubMed 33424664Garakani A, Murrough JW, Freire RC, Thom RP, Larkin K, Buono FD, Iosifescu DV. Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options. Front Psychiatry. 2020 Dec 23;11:595584. doi: 10.3389/fpsyt.2020.595584. eCollection 2020.
- Link to more information and study recruitment for interested potential participants.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Meltzer-Brody, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At-Home Stimulation in people with Generalized Anxiety Disorder, run by Electromedical Products International, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) change (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06124014, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.