Study to Evaluate the Safety and Efficacy of PEER Interactive Versus Treatment as Usual in Subjects With a Primary Diagnosis of Depression
Paused · Not applicable
Conditions studied: Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT01794559
- Run by
- MYnd Analytics
- People needed
- 1922
- Starts
- 2013-03-01
- Expected to finish
- 2022-06-30
- Last updated by the study team
- 2020-07-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
- Fort Belvoir Community Hospital — Fort Belvoir, Virginia, United States
Full record on ClinicalTrials.gov
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