Brief Summary

The MYnd Analytics PEER Online strategy utilizes EEG diagnostics to direct patients with psychiatric illnesses to the best medication treatments. This trial will evaluate patients with a diagnosis of depression who will either receive (1) PEER Online directed therapy or (2) conventional treatment without EEG guidance and will compare 6 month clinical and economic outcomes between these groups.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

600

participants targeted

Target at P75+ for phase_4 depression

Timeline

Completed

Started Oct 2017

Geographic Reach

1 country

16 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

October 1, 2017

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed

Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

October 27, 2017

Last Update Submit

November 1, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

50% Reduction From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16)
QIDS-SR-16 is a 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe). This study will examine the percentage of patients with improvement in depression as assessed by the QIDS-SR-16 at the 6 month treatment visit \[repeated measures from all visits - for patients who received the intervention ie. MD followed PEER recommended therapy\]. Response will be defined as a \>50% reduction in QIDS-SR-16 score from baseline.
6 months

Secondary Outcomes (2)

Clinical improvement based on physician access to MyND Analytic PEER Online report.
6 months
Persistence of PEER recommended therapy.
3 months

Other Outcomes (2)

Total cost of care.
6 months
Exploring use of Cota Nodal Address (CNA)
6 months

Study Arms (2)

MYnd Analytics PEER Online directed therapy

EXPERIMENTAL

Patients in this arm will receive anti-depressants as recommended by the PEER Online algorithm as described below.

Device: MYnd Analytics PEER Online directed antidepressant therapy

Conventional therapy

SHAM COMPARATOR

Patients in this arm will receive anti-depressants as chosen by the physician without guidance by the PEER Online algorithm.

Other: Conventional antidepressant therapy

Interventions

MYnd Analytics PEER Online directed antidepressant therapyDEVICE

PEER Online is similar to a standard QEEG in that it uses QEEG output variables, but differs from a standard QEEG in that it references the QEEG to a normative and then symptomatic database. By comparing a given patient's QEEG to a database of QEEGs of subjects who have tried and responded to a specific medication, PEER Online can provide useful information regarding the response of neuro-physiologically similar patients to a wide number of medications. PEER Online may thus have the advantage of providing physicians with useful information as to medication outcomes before a medication regime is started. It has also been used to help select the medication that best matches the QEEG brainwave pattern, regardless of "symptom clusters," currently used for diagnostic nomenclature. Patients will receive anti-depressant therapy guide by the results of the PEER Online algorithm.

MYnd Analytics PEER Online directed therapy

Conventional antidepressant therapyOTHER

Anti-depressant therapy chosen based on physician best judgement.

Conventional therapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with a clinical diagnosis of depression who in the judgement of their physician require medication management may be eligible for enrollment. A score of 10 or more on the PHQ-9 instrument will be required for enrollment.
Some practices utilize the PHQ-2 and PHQ-9 are part of routine screening for depression. If the tests are performed routinely, they do not need to be repeated for study eligibility, and may be performed prior to informed consent for this study. If, however, the PHQ-9 is not routinely performed, informed consent must be performed prior to administration. Patients with a score below 10 will be considered screen failures and will not be enrolled or offered the MYnd testing.
Patients with non-psychotic comorbid conditions may be included.
Patients must be either medication treatment naïve for behavioral illnesses or have no active medication treatments for at least 1 month prior to enrollment. Prohibited medications at the time of enrollment will include stimulants, benzodiazepines and THC. Prior therapy with these agents is permitted with a washout of \>30 days.
Patients must have private medical insurance coverage through Horizon Blue Cross Blue Shield. This is limited to insured commercial members, including HMO, and excluding, for the avoidance of doubt, members of self-insured customers or Medicare or Medicaid programs.

You may not qualify if:

Diagnosis of a psychotic disorder.
History of, or current, open head brain trauma. Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG
History of: craniotomy, cerebral metastases, cerebrovascular accident; current diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
Uncontrolled thyroid disorders.
Known pregnancy and/or lactation, or intent to become pregnant during this study.
Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic)

Contact the study team to confirm eligibility.