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



Status:Recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:11/2/2018
Start Date:March 1, 2013
End Date:June 30, 2020
Contact:Stewart Navarre, MBA
Email:snavarre@myndanalytics.com
Phone:949-293-1863

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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.

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.

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.
We found this trial at
2
sites
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Brett Schneider, MD
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Fort Belvoir, Virginia 22060
Principal Investigator: Mekeshia Bates, DNP, MPH, MSN, CRNP-PMH,RN
Phone: 571-231-4628
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Fort Belvoir, VA
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