Depressive Disorder Clinical Trial
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.
NCT number | NCT01794559 |
Other study ID # | CNSR011 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2013 |
Est. completion date | June 30, 2022 |
Verified date | July 2020 |
Source | MYnd Analytics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 1922 |
Est. completion date | June 30, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Fort Belvoir Community Hospital | Fort Belvoir | Virginia |
Lead Sponsor | Collaborator |
---|---|
MYnd Analytics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Subjects with Adverse Events as a Measure of Safety and Tolerability | 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. | 6 months | |
Primary | Quick Inventory of Depressive Symptomatology - Self Reported 16 (QIDS-SR16) | 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. | 6 months | |
Secondary | Clinical Global Impression (CGI) | 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 | 6 months | |
Secondary | Concise Health Risk Tracking (CHRT-7SR) | 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. | 6 months | |
Secondary | Post traumatic stress disorder checklist - civilian | A 17 question self-reported measure of the Diagnostic and Statistical Manual (DSM)-IV symptoms of PTSD. | 6 months | |
Secondary | Maximum Medical Improvement (MMI) | At what point in time, if ever, does the subject reach their maximum medical improvement. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01316926 -
Paxil CR Bioequivalence Study Brazil
|
Phase 1 | |
Recruiting |
NCT06187454 -
Transcranial Direct Current Stimulation for Depression
|
N/A | |
Completed |
NCT04469322 -
Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression
|
N/A | |
Recruiting |
NCT05768126 -
Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine
|
Phase 4 | |
Completed |
NCT03219879 -
Telephone-administered Relapse Prevention for Depression
|
N/A | |
Recruiting |
NCT06038721 -
Unified Protocol: Community Connections
|
N/A | |
Completed |
NCT03043560 -
Study to Treat Major Depressive Disorder With a New Medication
|
Phase 2 | |
Completed |
NCT04091139 -
Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
|
Phase 2/Phase 3 | |
Completed |
NCT00069459 -
Seasonal Affective Depression (SAD) Study
|
Phase 1 | |
Recruiting |
NCT05503966 -
Combining Antidepressants and Attention Bias Modification in Depression
|
N/A | |
Recruiting |
NCT03001245 -
Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents
|
N/A | |
Completed |
NCT02939560 -
TMS for Adults With Autism and Depression
|
N/A | |
Completed |
NCT02542891 -
European Comparative Effectiveness Research on Internet-based Depression Treatment
|
N/A | |
Completed |
NCT02452892 -
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
|
N/A | |
Withdrawn |
NCT02238730 -
Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy
|
N/A | |
Completed |
NCT02224508 -
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
|
N/A | |
Completed |
NCT02306551 -
Well Being And Resilience: Mechanisms of Transmission of Health and Risk
|
||
Completed |
NCT01407575 -
Buprenorphine for Treatment Resistant Depression
|
Phase 3 | |
Completed |
NCT01597661 -
Bupropion & Cardio Birth Defect (Slone)
|
N/A | |
Completed |
NCT01093053 -
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
|
N/A |