Status:
SUSPENDED
Study to Evaluate the Safety and Efficacy of PEER Interactive Versus Treatment as Usual in Subjects With a Primary Diagnosis of Depression
Lead Sponsor:
MYnd Analytics
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
1922 Patients enrolled
Trial Details
Trial ID
NCT01794559
Start Date
March 1 2013
End Date
June 30 2022
Last Update
July 31 2020
Active Locations (2)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
2
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060