rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure

Completed · Not applicable

Conditions studied: Depressive Disorder

In brief

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 modified Star\*D Algorithm. Qualified subjects will be randomized to the experimental (rEEG guided) group, or the control group and treated for 12 weeks. Medications utilized in this study are currently marketed. All visits, physical exam, rEEG, labs, rating scales and medications are provided at no cost to the patient.

Key facts

Study ID

NCT00437827

Run by

MYnd Analytics

People needed

120

Starts

2006-08-01

Expected to finish

2009-10-01

Last updated by the study team

2009-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Behavioral Research Specialists — Glendale, California, United States
• University of California - Irvine — Irvine, California, United States
• Shanti Research and Clinical Trials — San Bernardino, California, United States
• Stanford University — Stanford, California, United States
• Elite Clinical Trials — Wildomar, California, United States
• Radiant Research — Denver, Colorado, United States
• Hawaii Clinical Research Center — Honolulu, Hawaii, United States
• Rush University — Chicago, Illinois, United States
• McClean Hospital/Harvard — Belmont, Massachusetts, United States
• Harvard Medical School - Cambridge Hospital — Cambridge, Massachusetts, United States
• Alpha Behavioral Care, P.A. — Summit, New Jersey, United States
• Cornell University — New York, New York, United States
• Univ of TX Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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