Medibio DDA Confirmatory Performance Study

Completed

Conditions studied: Major Depressive Episode

In brief

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.

Key facts

Study ID

NCT03529513

Run by

Medibio Limited

People needed

234

Starts

2017-08-18

Expected to finish

2018-05-04

Last updated by the study team

2023-12-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CNS Network — Garden Grove, California, United States
• CNS Network — Torrance, California, United States
• Lindner Center of HOPE — Mason, Ohio, United States
• OCCI, Inc. — Salem, Oregon, United States
• FutureSearch Trials — Dallas, Texas, United States
• White River Junction Veterans Affairs Medical Center — White River Junction, Vermont, United States
• Epworth Clinic — Camberwell, Victoria, Australia
• The Melbourne Clinic — Richmond, Victoria, Australia

Full record on ClinicalTrials.gov

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