Not provided
Not provided
Not provided
Not provided
Not provided
No site recruitment due to Covid-19
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Concise Health Risk Tracking (CHRT-7SR) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events as a Measure of Safety and Tolerability | 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. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Iosifescu, MD, PhD | Langone Center, NYU | Principal Investigator |
| Michael Metzig, BA | MYnd Analytics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States | ||
| Fort Belvoir Community Hospital |
We do not plan to share individual participant data with other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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
|
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.
| 6 months |
| Post traumatic stress disorder checklist - civilian | A 17 question self-reported measure of the Diagnostic and Statistical Manual (DSM)-IV symptoms of PTSD. | 6 months |
| Maximum Medical Improvement (MMI) | At what point in time, if ever, does the subject reach their maximum medical improvement. | 6 months |
| Fort Belvoir |
| Virginia |
| 22060 |
| United States |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
Not provided
Not provided