- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01794559
Study to Evaluate the Safety and Efficacy of PEER Interactive Versus Treatment as Usual in Subjects With a Primary Diagnosis of Depression
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Bethesda, Maryland, United States, 20889
- Walter Reed National Military Medical Center
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Virginia
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Fort Belvoir, Virginia, United States, 22060
- Fort Belvoir Community Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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 Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quick Inventory of Depressive Symptomatology - Self Reported 16 (QIDS-SR16)
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression (CGI)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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
Time Frame: 6 months
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A 17 question self-reported measure of the Diagnostic and Statistical Manual (DSM)-IV symptoms of PTSD.
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6 months
|
Maximum Medical Improvement (MMI)
Time Frame: 6 months
|
At what point in time, if ever, does the subject reach their maximum medical improvement.
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6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Iosifescu, MD, PhD, Langone Center, NYU
- Study Director: Michael Metzig, BA, MYnd Analytics, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNSR011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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