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

NCT02988076 | Suspended Phase 2 DMC

• 1 other identifier: CNSR012
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

database; probability; response; depression; medication; quantitative; electroencephalogram

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomatology - Self Report 16 questionnaire (QIDS-SR16)

  A self reported survey - blinded subject acts as blinded rater/outcomes assessor. We will use this survey to measure the subject's self-reported change in symptoms of depression.

  4 months

Secondary Outcomes (3)

• Clinical Global Impressions - Improvement (CGI-I)

  4 months

• Clinical Global Impressions - Severity (CGI-S)

  4 months

• Concise Health Risk Tracking Scale - 7 item Self Report Survey (CHRT- SR7)

  4 months

Study Arms (2)

Control

NO INTERVENTION

The Control group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Treatment/Experimental group. A clinician treating a Control Group subject will NOT receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.

Treatment

ACTIVE COMPARATOR

Intervention - Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report - Treatment group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Control group. A clinician treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.

Device: PEER Interactive Report

Interventions

PEER Interactive Report DEVICE

A subinvestigator treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. A subinvestigator treating a Control Group subject will NOT receive the PEER Report and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.

Also known as: PEER Report

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.
• 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.

Sponsors & Collaborators

• MYnd Analytics: lead
• Mount Sinai Hospital, New York: collaborator

Study Sites (1)

Carolina Partners

Raleigh, North Carolina, 27609, United States

Location

Related Publications (6)

• DeBattista C, Kinrys G, Hoffman D, Goldstein C, Zajecka J, Kocsis J, Teicher M, Potkin S, Preda A, Multani G, Brandt L, Schiller M, Iosifescu D, Fava M. The use of referenced-EEG (rEEG) in assisting medication selection for the treatment of depression. J Psychiatr Res. 2011 Jan;45(1):64-75. doi: 10.1016/j.jpsychires.2010.05.009. Epub 2010 Jul 3.

  PMID: 20598710 BACKGROUND

• Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.

  PMID: 19333404 BACKGROUND

• Duffy FH, Burchfiel JL, Lombroso CT. Brain electrical activity mapping (BEAM): a method for extending the clinical utility of EEG and evoked potential data. Ann Neurol. 1979 Apr;5(4):309-21. doi: 10.1002/ana.410050402.

  PMID: 443765 BACKGROUND

• Hughes JR, John ER. Conventional and quantitative electroencephalography in psychiatry. J Neuropsychiatry Clin Neurosci. 1999 Spring;11(2):190-208. doi: 10.1176/jnp.11.2.190.

  PMID: 10333991 BACKGROUND

• Hoffman DA, Debattista C, Valuck RJ, Iosifescu DV. Measuring severe adverse events and medication selection using a "PEER Report" for nonpsychotic patients: a retrospective chart review. Neuropsychiatr Dis Treat. 2012;8:277-84. doi: 10.2147/NDT.S31665. Epub 2012 Jun 21.

  PMID: 22802691 BACKGROUND

• Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. doi: 10.1016/j.biopsych.2005.08.022. Epub 2005 Sep 30.

  PMID: 16199008 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Daniel Iosifescu, PhD

  Mount Sinai Hospital, New York, N.Y.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The subject is masked as to assignment to Control or Treatment Group. The subject acts as the blinded rater - providing the primary outcome measure - the Quick Inventory of Depressive Symptomatology - 16 Item Self report
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)