Study to Evaluate the Safety and Efficacy of PEER Interactive to Inform Medication Prescription for Subjects With a Primary Diagnosis of Depression

Paused · Phase 2/Phase 3

Conditions studied: Depression

In brief

This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform medication prescription in subjects with a primary diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus treatment as usual, as determined by the investigator. The primary measurement for improvement of the subjects depression will be a self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report 16 , but the investigators will also collect information on their clinical global improvement and any reduction in adverse events.

Key facts

Study ID

NCT02988076

Run by

MYnd Analytics

People needed

468

Starts

2016-11-01

Last updated by the study team

2020-07-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects between the ages of 18 - 65 years of age or older who speak and read English.
• Subjects able to provide written informed consent to participate in the study.
• Subjects with a primary diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) depressive disorder. Please see Appendix D for definitions.
• Subjects with comorbidity of a non-psychotic behavioral disorder. Please see Appendix D for definitions.
• Subjects with comorbidity of mild traumatic brain injury (mTBI) are eligible for inclusion in this study.
• Subjects with comorbidity of post-traumatic stress disorder (PTSD) are eligible for inclusion in this study. A score of 45 or greater on the PTSD Checklist Civilian (PCL-C) measurement tool will qualify a subject for inclusion of diagnosis of PTSD as a comorbid condition.
• Able to stop specified medications, including drugs of abuse, for 5 half-lives of the medication(s). See Appendix E for a list of the withdrawal periods for medications. The potential subject's primary care physician may be consulted to make these determinations.
• Able to be washed out of medications within 14 days, i.e. 5 half-lives are not longer than 14 days (See Appendix E).
• Ability to comply with the requirements of the study.

You may not qualify if…

• Male and female subjects less than 18 years old or greater than 65 years old.
• Subjects who cannot provide written informed consent.
• Diagnosis of a psychotic disorder. Please see Appendix D for definitions.
• History of, or current, open head brain trauma.
• Subjects with comorbidity of traumatic brain injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24 hours) of less than 13.
• Subjects who, in the opinion of the investigator would not be good candidates to be washed out of specified medications (Appendix E) and are unable to washout medications and/or supplements in a period of 14 days or less.
• 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.
• Clinically significant medical illness, including thyroid disorders, diabetes, etc., which cannot be remediated with medication, e.g. synthroid, insulin, etc.
• Participation in any other therapeutic drug study within 60 days preceding inclusion.
• 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).
• Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG.
• Candidates currently stable on current medications.
• Pre-entry subject whose urine drug screen is positive for drugs of abuse.

Where it is running

• Carolina Partners — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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