Medibio DDA Confirmatory Performance Study
Medibio DDA Confirmatory Performance Study
This study will determine whether the Medibio Depression Diagnostic Aid exceeds minimally
 acceptable thresholds for sensitivity and sensitivity in cases with a current depression
 episode and non-depressed controls.
Subjects meeting study criteria will be enrolled into one of two study cohorts: a) outpatient
 individuals with current, moderate-to-severe major depressive episode (experimental group)
 and b) individuals without current major depressive episode that have been matched at the
 group level for age and gender (control group).

 All subjects will undergo two separate psychiatric interviews to confirm current depression
 episode presence or absence. Thereafter subjects will wear a heart rate monitor on the chest
 to capture data over the course of 72 hours. Subjects will return approximately 1 week after
 initial placement of the monitor for equipment return and a safety check. Subjects will wear
 a heart-rate monitor over the course of 72 hours. Subjects will return within a week from the
 last visit for equipment return.
All Subjects:

 Inclusion Criteria:

 -  Subject is willing and able to provide consent.

 -  Subject has ability to read and understand the instructions for the study.

 -  Subject is willing to adhere to study procedures.

 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.

 Depressed Cohort Inclusion Criteria: Subject has current moderate or severe Major
 Depressive Disorder Episode, based on DSM-IV criteria for diagnosis as documented by
 clinician administered M.I.N.I plus HAMD-17 rating scale score ≥17.

 Exclusion Criteria: Subject has presence of no or mild Major Depressive Disorder Episode,
 based on DSM-IV criteria for diagnosis as documented by clinician administered M.I.N.I OR
 HAMD-17 rating scale score <17.

 Control Cohort Inclusion Criteria: Subject has no presence of mild, moderate, or severe
 Major Depressive Disorder Episode, based on DSM-IV criteria for diagnosis as documented by
 clinician administered M.I.N.I AND HAMD-17 rating scale score ≤7.

 Exclusion Criteria: Subject has presence of mild, moderate, or severe Major Depressive
 Disorder Episode, based on DSM-IV criteria for diagnosis as documented by clinician
 administered M.I.N.I OR HAMD-17 rating scale score >7.