Clinical trial NCT02988076: Study to Evaluate the Safety and Efficacy of PEER Interactive to Inform Medication Prescription for Subjects With a Primary Diagnosis of Depression
Official title: A Prospective, Double Blind, Randomized, Controlled, Multisite Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform Medication Prescription to Subjects With a Primary Diagnosis of a Depressive Disorder(SMART-MD)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Depression
Keywords: database
probability
response
depression
medication
quantitative
electroencephalogram
Lead sponsor: MYnd Analytics
Sponsor class: INDUSTRY
Collaborators: name: Mount Sinai Hospital, New York
First posted: 2016-12-09
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study is prospective in nature. Subjects in the control group will be treated according to treatment as usual and best judgment of the treating physician. For the experimental group the treating physician will follow the guidance of the subject's PEER Interactive Report as regards sensitivity to on-label medications and classes of medication.

The subjects will be washed out of all current medications prior to having an electroencephalogram (EEG), which is necessary to generate the PEER Interactive Report. The wash out period for outpatients is no longer than 14 days.

The subjects will be followed for 3 months after the initial treatment. The patient will be seen on a routine basis and assessments will be made at each interaction to evaluate the patient's improvement in mental health. The subjects will also be closely evaluated to determine if they are experiencing any psychiatric specific adverse events. The investigator is allowed to treat the patient according to their best medical judgment, which may include adding or changing medications, seeing the patient more frequently, or other interventions such as the use of sleep aids.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects between the ages of 18 - 65 years of age or older who speak and read English.
2. Subjects able to provide written informed consent to participate in the study.
3. Subjects with a primary diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) depressive disorder. Please see Appendix D for definitions.
4. Subjects with comorbidity of a non-psychotic behavioral disorder. Please see Appendix D for definitions.
5. Subjects with comorbidity of mild traumatic brain injury (mTBI) are eligible for inclusion in this study.
6. 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.
7. 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.
8. Able to be washed out of medications within 14 days, i.e. 5 half-lives are not longer than 14 days (See Appendix E).
9. Ability to comply with the requirements of the study.

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Exclusion Criteria:

1. Male and female subjects less than 18 years old or greater than 65 years old.
2. Subjects who cannot provide written informed consent.
3. Diagnosis of a psychotic disorder. Please see Appendix D for definitions.
4. History of, or current, open head brain trauma.
5. 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.
6. 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.
7. 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.
8. Clinically significant medical illness, including thyroid disorders, diabetes, etc., which cannot be remediated with medication, e.g. synthroid, insulin, etc.
9. Participation in any other therapeutic drug study within 60 days preceding inclusion.
10. Known pregnancy and/or lactation, or intent to become pregnant during this study.
11. Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
12. Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG.
13. Candidates currently stable on current medications.
14. Pre-entry subject whose urine drug screen is positive for drugs of abuse.

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Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Self Report 16 questionnaire (QIDS-SR16)
timeFrame: 4 months
Secondary outcomes:
measure: Clinical Global Impressions - Improvement (CGI-I)
timeFrame: 4 months
measure: Clinical Global Impressions - Severity (CGI-S)
timeFrame: 4 months
measure: Concise Health Risk Tracking Scale - 7 item Self Report Survey (CHRT- SR7)
timeFrame: 4 months
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Carolina Partners
state: North Carolina
Study officials:
affiliation: Mount Sinai Hospital, New York, N.Y.
name: Daniel Iosifescu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.