Status:
COMPLETED
rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
Lead Sponsor:
MYnd Analytics
Conditions:
Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is testing a process (rEEG)for selecting the most appropriate medication(s) to treat a patient's depression versus a control group being treated according to a standardized method, the modi...
Detailed Description
This study is testing a process (rEEG)for selecting the most appropriate medication(s) to treat a patient's depression versus a control group being treated according to a standardized method, the modi...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Diagnosis of Major Depressive Disorder validated by SCID. Subjects may meet criteria for both melancholic and atypical depression per this protocol.
- Have failed three or more antidepressant regimens during the current depressive episode with minimum daily dose(s) as defined in the Medication History for Depression Case Report Form and for a minimum duration of treatment of at least 4 weeks. For purposes of the Study, augmentation will be considered a separate regimen.
- Able to stop all medications for 5 half-lives of the medication(s), with the exception of hormones, thyroid, hydrochlorthiazide and Ambien. See Appendix II for a list of the half-lives of medications.
Exclusion
- History of: closed head injury with unconsciousness, craniotomy, cerebral metastases, cerebrovascular accident; no current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, substance abuse, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
- Participation in any other therapeutic drug study evaluating a treatment for depression within 60 days preceding inclusion, unless drug(s) half-life is known.
- Known pregnancy and/or lactation, or intent to become pregnant during this study.
- Doesn't qualify via rEEG analysis due to:
- Potential physiologic abnormality
- Low abnormality in comparison to current rEEG database
- No strong prediction by rEEG analysis for any particular medication class
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00437827
Start Date
August 1 2006
End Date
October 1 2009
Last Update
October 27 2009
Active Locations (13)
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1
Behavioral Research Specialists
Glendale, California, United States, 91204
2
University of California - Irvine
Irvine, California, United States, 92868
3
Shanti Research and Clinical Trials
San Bernardino, California, United States, 92324
4
Stanford University
Stanford, California, United States, 94305-5401