CES for the Treatment of GAD in Young Adults

Generalized Anxiety Disorder Clinical Trial

Official title:

Cranial Electrotherapy Stimulation (CES) for the Treatment of Generalized Anxiety Disorder (GAD) in Young Adults: Double-Blind Sham-Controlled Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124014
• Other study ID #: 22-3341
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Electromedical Products International, Inc.
• Contact: Tobias Schwippel, MD
• Phone: 919-966-9929
• Email: tobias_schwippel[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 21 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

• 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Device:
• At-Home Stimulation
The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.

Locations

Country	Name	City	State
United States	Carolina Center for Neurostimulation	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Electromedical Products International, Inc.	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bandelow 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. — View Citation

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. — View Citation

Garakani 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. — View Citation

Goodwin 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. — View Citation

Hajek 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	42 days
Secondary	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.	84 days
Secondary	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.	42 days
Secondary	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.	84 days
Secondary	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.	42 days
Secondary	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.	84 days
Secondary	Response/Remission of anxiety	Response/remission rates based on HAM-A scores from FU1 versus baseline D1	42 days
Secondary	Response/Remission of anxiety	Response/remission rates based on HAM-A scores from FU2 versus baseline D1	84 days
Secondary	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.	42 days
Secondary	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.	84 days
Secondary	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.	42 days
Secondary	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.	84 days

External Links

•   Link to more information and study recruitment for interested potential participants.