CES for the Treatment of GAD in Young Adults (NCT06124014) | Clinical Trial Compass
CompletedNot Applicable
CES for the Treatment of GAD in Young Adults
United States130 participantsStarted 2024-01-26
Plain-language 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.
Who can participate
Age range18 Years – 21 Years
SexALL
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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 stimulat…
What they're measuring
1
Hamilton Anxiety Rating Scale (HAM-A) change
Timeframe: 42 days
Trial details
NCT IDNCT06124014
SponsorElectromedical Products International, Inc.