Medibio DDA Confirmatory Performance Study

Exclusion Criteria

• •Subject has active psychotic symptoms.
• •Subject has bipolar disorder.
• •Subject has known, or is suspected to have a personality disorder.
• •Subject has current suicidality of medium or high risk as determined by M.I.N.I. or HAMD-17 item #3 score of 3 of higher.
• •Subject has history of central or obstructive sleep apnea OR STOP-BANG questionnaire score of ≥5.
• •Subject has a pacemaker.
• •Subject currently uses benzodiazepines on a scheduled basis.
• •Subject currently uses chronotropic medication, such as beta-blockers, digoxin, sinoatrial/atrioventricular nodal-acting calcium channel blockers, or amiodarone.
• •Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).
• •Subject has a terminal illness.
• •For female subjects, subject is currently known to be pregnant or lactating.
• •Subject has any other acute or chronic condition that in the investigators opinion would preclude the subject from being able to meet all of the protocol requirements, or would compromise the subject's safety during participation in the study, as judged by the investigator.
• •Subject is currently participating in another clinical study. Subject currently uses antipsychotic medication for any indication.