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Trial record 19 of 6091 for:    "Depressive Disorder" [DISEASE]

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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ClinicalTrials.gov Identifier: NCT01794559
Recruitment Status : Recruiting
First Posted : February 20, 2013
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
CNS Response

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Device: PEER Interactive Report Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1922 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes 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

Primary Purpose: Treatment
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 Start Date : March 1, 2013
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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.

Device: 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.

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Post traumatic stress disorder checklist - civilian [ Time Frame: 6 months ]
    A 17 question self-reported measure of the Diagnostic and Statistical Manual (DSM)-IV symptoms of PTSD.

  4. Maximum Medical Improvement (MMI) [ Time Frame: 6 months ]
    At what point in time, if ever, does the subject reach their maximum medical improvement.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794559


Contacts
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Contact: Stewart Navarre, MBA 949-293-1863 snavarre@myndanalytics.com

Locations
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United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Brett Schneider       Brett.J.Schneider.mil@health.mil   
Principal Investigator: Brett Schneider, MD         
United States, Virginia
Fort Belvoir Community Hospital Recruiting
Fort Belvoir, Virginia, United States, 22060
Sponsors and Collaborators
CNS Response
Investigators
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Principal Investigator: Daniel Iosifescu, MD, PhD Langone Center, NYU
Study Director: Stewart Navarre, MBA MYnd Analytics, Inc.

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Responsible Party: CNS Response
ClinicalTrials.gov Identifier: NCT01794559     History of Changes
Other Study ID Numbers: CNSR011
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
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

Keywords provided by CNS Response:
Depression, EEG, QEEG, mTBI, PTSD, efficiency, safety, suicidality

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms