Status:
UNKNOWN
MYnd Analytics Directed Therapy in Depression
Lead Sponsor:
Cota Inc.
Collaborating Sponsors:
Hackensack Meridian Health
Horizon Blue Cross Blue Shield of New Jersey
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Detailed Description
Mynd Analytics has developed the Psychiatric Electroencephalography Evaluation Registry (PEER) Online® clinical decision support database that uses a combination of software, analytics, and clinical o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- Participation in any other therapeutic drug study within 60 days preceding inclusion.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03328052
Start Date
October 1 2017
End Date
October 1 2020
Last Update
November 6 2017
Active Locations (16)
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1
Hackensack Meridian Health Network
Brick, New Jersey, United States, 08723
2
Hackensack Meridian Health Network
Brick, New Jersey, United States, 08724
3
Hackensack Meridian Health Network
Hackensack, New Jersey, United States, 07601
4
Hackensack Meridian Health Network
Hackensack, New Jersey, United States, 07601