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
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
Overall status: SUSPENDED
Phase: NA
Conditions: Depressive Disorder
Keywords: Depression, EEG, QEEG, mTBI, PTSD, efficiency, safety, suicidality
Lead sponsor: MYnd Analytics
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 1922
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Self Reported 16 (QIDS-SR16)
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: 6 months
measure: Concise Health Risk Tracking (CHRT-7SR)
timeFrame: 6 months
measure: Post traumatic stress disorder checklist - civilian
timeFrame: 6 months
measure: Maximum Medical Improvement (MMI)
timeFrame: 6 months
Other outcomes:
measure: Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 months
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
Study officials:
affiliation: Langone Center, NYU
name: Daniel Iosifescu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MYnd Analytics, Inc.
name: Michael Metzig, BA
role: STUDY_DIRECTOR
References: