CES for the Treatment of GAD in Young Adults

Inclusion Criteria:

• Capable of signing informed consent form.

• Stated willingness to comply with all study procedures and availability for theduration of the study including refraining from changes to treatment unlessmedically 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 higheron the clinician-administered HAM-A at the screening visit.

• Concurrent psychiatric medications are allowed. Participants will be required tomaintain a sable dose of medications, or remain medication free, for 2 weeks priorto the screening visit, except for antidepressants for which the period of stabledose 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 thescreening 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 CESdevice.

• Inability to tolerate the required minimum stimulation amplitude (200 uA) during theinitial device training at the baseline visit.

• Experimental or clinical brain stimulation such as deep brain stimulation ortranscranial magnetic stimulation for any indication (current or within 60 daysprior 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 severealcohol 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 psychoticfeatures, bipolar I with psychotic features, anorexia nervosa.

• Epilepsy (current or history). History of febrile childhood seizures andnon-epileptic seizures are allowed.

• Pregnant or breast-feeding.

• Enrollment in clinical trial for any condition (current or within 60 days prior toscreening 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 unadvisablein the assessment of a study clinician.