Clinical trial NCT06124014: CES for the Treatment of GAD in Young Adults
Official title: Cranial Electrotherapy Stimulation (CES) for the Treatment of Generalized Anxiety Disorder (GAD) in Young Adults: Double-Blind Sham-Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: CES
Lead sponsor: Electromedical Products International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2023-11-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A) change
timeFrame: 42 days
Secondary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A) change
timeFrame: 84 days
measure: Beck Anxiety Inventory (BAI) Change
timeFrame: 42 days
measure: Beck Anxiety Inventory (BAI) Change
timeFrame: 84 days
measure: Generalized-Anxiety Disorder 7-item (GAD-7) Change
timeFrame: 42 days
measure: Generalized-Anxiety Disorder 7-item (GAD-7) Change
timeFrame: 84 days
measure: Response/Remission of anxiety
timeFrame: 42 days
measure: Response/Remission of anxiety
timeFrame: 84 days
measure: Change in Clinical Global Impression Scale (CGI)
timeFrame: 42 days
measure: Change in Clinical Global Impression Scale (CGI)
timeFrame: 84 days
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
timeFrame: 42 days
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
timeFrame: 84 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Carolina Center for Neurostimulation
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Samantha Meltzer-Brody, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.