Recruiting

MYnd AnalyticsMYnd Analytics Directed Therapy in Depression

Sponsor:

Cota Inc.

Code:

NCT03328052

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MYnd Analytics PEER Online directed antidepressant therapy

Conventional antidepressant therapy

Study Details

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.

Conditions

Depression

Study ID

NCT03328052

Start date

Oct 1, 2017

Status verified date

Nov, 2017

Completion date

Oct 1, 2020

Anticipated

Primary completion date

Oct 1, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MYnd Analytics PEER Online directed therapy

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

sham comparator: Conventional therapy

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

Interventions

MYnd Analytics PEER Online directed antidepressant therapy

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.

Conventional antidepressant therapy

Anti-depressant therapy chosen based on physician best judgement.

Primary outcome measure

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) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Ramon Solhkhah, MD

732-776-4930 ramon.solhkhah@hackensackmeridian.org

Stuart Goldberg, MD

201-741-0566 stuartgoldberg@cotahealthcare.com

Locations