rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Blinded, Controlled, Parallel Group Trial to Demonstrate the Efficacy of rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure|
- Two group comparison of QIDS-SR16 and Q-LES-Q-SF [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
- Two group comparison of MADRS, Clinical Global Improvement and Severity. [ Time Frame: after 12 weeks of therapy ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Each subject in this arm will receive depression therapy similar to that used by the Star*D study - a major depression study conducted in the United States (Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Am J Psychiatry 2006; 163:1905-1917)
Other: Star*D algorithm
Standard of care based upon the therapies selected in the Star*D study.
Other Name: Standard of Care
Each subject in this arm will receive therapy based upon an individualized rEEG report which provides one or more treatment options with the highest probability of success.
Other: rEEG-guided therapy
An rEEG report is based upon a process that utilizes a patient's drug-free QEEG to predict successful treatment strategies.
Other Name: EEG-based technology
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 10 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.
To qualify for entry into the study, patients must be:
- 18 years of age or older.
- Diagnosis of Major Depressive Disorder. Subjects may meet criteria for both melancholic and atypical depression.
- Have failed 1 or more SSRIs, or have failed 2 or more antidepressants in at least 2 drug classes.
And patients must not have:
- 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.
- Known pregnancy and/or lactation, or intent to become pregnant during this study.
Medications that can be used in this study are:
Anti-depressants: fluoxetine, sertraline, paroxetine, desipramine, imipramine, nortriptyline,amitriptyline, clomipramine, bupropion, venlafaxine
Stimulants & MAO Inhibitors: moclobemide, tranylcypromine, selegiline, methylphenidate, dextroamphetamine, dexlevoamphetamine, pemoline, lamotrigine, topiramate
Benzodiazepines: lorazepam, clonazepam, alprazolam
Anti-convulsants: carbamazepine, lithium, divalproex, gabapentin
Beta Blockers: metoprolol, propranolol, atenolol
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437827
|United States, California|
|Behavioral Research Specialists|
|Glendale, California, United States, 91204|
|University of California - Irvine|
|Irvine, California, United States, 92868|
|Shanti Research and Clinical Trials|
|San Bernardino, California, United States, 92324|
|Stanford, California, United States, 94305-5401|
|Elite Clinical Trials|
|Wildomar, California, United States, 92595|
|United States, Colorado|
|Denver, Colorado, United States, 80212|
|United States, Hawaii|
|Hawaii Clinical Research Center|
|Honolulu, Hawaii, United States, 96826|
|United States, Illinois|
|Chicago, Illinois, United States, 60612 / 60076|
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478-9106|
|Harvard Medical School - Cambridge Hospital|
|Cambridge, Massachusetts, United States, 02139|
|United States, New Jersey|
|Alpha Behavioral Care, P.A.|
|Summit, New Jersey, United States, 07901|
|United States, New York|
|New York City, New York, United States, 10021|
|United States, Texas|
|Univ of TX Health Science Center|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Charles DeBattista, MD||Stanford University|
|Principal Investigator:||Gustavo Kinrys, M.D.||Cambridge Hospital|
|Principal Investigator:||Steven G Potkin, MD||University of California, Irvine|
|Study Chair:||Daniel Hoffman, MD||CNS Response|