Study to Evaluate the Safety and Efficacy of PEER Interactive Versus Treatment as Usual in Subjects With a Primary Diagnosis of Depression

NCT01794559 | Suspended DMC FDA Device

• 1 other identifier: CNSR011
• Study Type: interventional
• Target: 1,922
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate the effectiveness of PEER Interactive to inform treatment 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, 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

Depressive Disorder

Keywords

Depression, EEG, QEEG, mTBI, PTSD, efficiency, safety, suicidality

Outcome Measures

Primary Outcomes (1)

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

  A 16 question self administer survey on the status of the subject's depression. The measurement will be taken until the completion of the study (6 months)or until the subject achieves maximum medical improvement.

  6 months

Secondary Outcomes (4)

• Clinical Global Impression (CGI)

  6 months

• Concise Health Risk Tracking (CHRT-7SR)

  6 months

• Post traumatic stress disorder checklist - civilian

  6 months

• Maximum Medical Improvement (MMI)

  6 months

Other Outcomes (1)

• Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

  6 months

Study Arms (2)

Informed by PEER Interactive Report

EXPERIMENTAL

The PEER Interactive Report -This study is prospective in nature. For subjects in 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 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 6 months after the initial treatment, or until the patient has achieved maximum medical improvement (MMI). 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.

Device: PEER Interactive Report

No Report

NO INTERVENTION

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. PEER Interactive Report is not provided to the investigator. The subjects will be followed for 6 months after the initial treatment, or until the patient has achieved maximum medical improvement (MMI). 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.

Interventions

PEER Interactive Report DEVICE

The PEER Interactive Report provides information comparing the subject's Quantitative Electroencephalography (QEEG) to a database of outcomes from patients with similar QEEG results, and how they responded to on-label treatments. This report provides a probability of how this subject will respond to treatment based upon a comparison of similar subjects in the database.

Informed by PEER Interactive Report

Eligibility Criteria

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

You may qualify if:

• Must speak and read English
• Must be able to provide written informed consent
• A primary diagnosis of a DSM-IV depressive disorder
• Co-morbidities of non-psychotic behavioral disorders, including PTSD and mild Traumatic Brain Injury (mTBI) are eligible to participate.
• Able to stop all medications (wash out) for 5 half-lves of all medication(s) which affect the EEG. Outpatient subjects are eligible if they can be washed out of their medications in 14 days or less.
• Ability to comply with the requirements of the study

You may not qualify if:

• Diagnosis of a psychotic disorder
• History of, or current, open head trauma
• Subjects who would not be good candidates to be washed out of their medications, in the opinion of the investigator.
• History of craniotomy, cerebral metastases, cerebrovascular accident, current diagnosis of seizure disorder, bipolar disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features, or use of depot neuroleptics in the last 12 months.
• Clinically significant medical illness, including thyroid disorders.
• Know pregnancy and/or lactation, or intent to become pregnant during the study.
• Chronic or acute pain requiring prescription medication(s).
• Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG
• Candidates that are currently stable and considered to be at maximum medical improvement on current medications.

Sponsors & Collaborators

• MYnd Analytics: lead

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, 22060, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression; Stress Disorders, Post-Traumatic; Suicidal Ideation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Suicide; Self-Injurious Behavior

Study Officials

• Daniel Iosifescu, MD, PhD

  Langone Center, NYU

  PRINCIPAL INVESTIGATOR

• Michael Metzig, BA

  MYnd Analytics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The subject is masked as to assignment to Control or Treatment Group. The blinded subject acts as the blinded rater in providing the primary outcome measure of the QIDS-SR16
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is prospective in nature. Control group subjects will be treated according to treatment as usual. Experimental group physicians will follow the guidance of the subject's PEER Interactive Report. Subjects will be washed out of medications prior to EEG. The wash out period for outpatients is no longer than 14 days. Subjects will be followed for 6 months after baseline, or until the patient has achieved maximum medical improvement (MMI). Subjects will be seen on a routine basis and assessments will be made at each interaction to evaluate the patient's improvement in mental health. Subjects will be closely evaluated for any psychiatric specific adverse events. The investigator is allowed to treat the patient according to 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.

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 20, 2013
• Study Start: March 1, 2013
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)