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

NCT ID: NCT01794559

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 1922 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-01
• Study Completion Date: 2022-06-30

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.

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 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. 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.

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Informed by PEER Interactive Report

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.

Group Type: EXPERIMENTAL

PEER Interactive Report

Intervention Type: 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.

No Report

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PEER Interactive Report

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Participation in any other therapeutic drug study within 60 days preceding inclusion in the study.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MYnd Analytics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Iosifescu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Langone Center, NYU

Michael Metzig, BA

Role: STUDY_DIRECTOR

MYnd Analytics, Inc.

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, United States

Countries

United States

Other Identifiers

CNSR011

Identifier Type: -

Identifier Source: org_study_id