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

Primary Purpose

Depressive Disorder

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PEER Interactive Report

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Depression, EEG, QEEG, mTBI, PTSD, efficiency, safety, suicidality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Walter Reed National Military Medical Center
Fort Belvoir Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Informed by PEER Interactive Report

No Report

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Global Impression (CGI)

A CGI for Improvement (CGI-I) and a CGI of Severity (CGI-S) will be measured at each visit during the study or until the subject reaches maximum medical improvement

Concise Health Risk Tracking (CHRT-7SR)

Self reported survey on suicidality will be conducted at each visit until the completion of the study or until the subject reaches maximum medical improvement.

Post traumatic stress disorder checklist - civilian

A 17 question self-reported measure of the Diagnostic and Statistical Manual (DSM)-IV symptoms of PTSD.

Maximum Medical Improvement (MMI)

At what point in time, if ever, does the subject reach their maximum medical improvement.

Full Information

NCT ID

NCT01794559

First Posted

February 14, 2013

Last Updated

July 29, 2020

Sponsor

MYnd Analytics

1. Study Identification

Unique Protocol Identification Number

NCT01794559

Brief Title

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

Official Title

A Prospective, Double Blind, Randomized, Multicenter Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform the Prescription of Medications to Patients With a Primary Diagnosis of a Depressive Disorder Versus Treatment as Usual.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Suspended

Why Stopped

No site recruitment due to Covid-19

Study Start Date

March 1, 2013 (undefined)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MYnd Analytics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

1922 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Informed by PEER Interactive Report

Arm Type

Experimental

Arm Description

Arm Title

No Report

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

PEER Interactive Report

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Clinical Global Impression (CGI)

Description

A CGI for Improvement (CGI-I) and a CGI of Severity (CGI-S) will be measured at each visit during the study or until the subject reaches maximum medical improvement

Time Frame

6 months

Title

Concise Health Risk Tracking (CHRT-7SR)

Description

Self reported survey on suicidality will be conducted at each visit until the completion of the study or until the subject reaches maximum medical improvement.

Time Frame

6 months

Title

Post traumatic stress disorder checklist - civilian

Description

A 17 question self-reported measure of the Diagnostic and Statistical Manual (DSM)-IV symptoms of PTSD.

Time Frame

6 months

Title

Maximum Medical Improvement (MMI)

Description

At what point in time, if ever, does the subject reach their maximum medical improvement.

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

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

Description

Noting the frequency and severity of psychiatric specific adverse events to determine if the information provided in the PEER Interactive Report results in providing treatment that was better tolerated than treatment as usual.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Iosifescu, MD, PhD

Organizational Affiliation

Langone Center, NYU

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael Metzig, BA

Organizational Affiliation

MYnd Analytics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Walter Reed National Military Medical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20889

Country

United States

Facility Name

Fort Belvoir Community Hospital

City

Fort Belvoir

State/Province

Virginia

ZIP/Postal Code

22060

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not plan to share individual participant data with other researchers.

Learn more about this trial

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

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