rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
- Conditions
- Depressive Disorder
- Interventions
- Other: Star*D algorithmOther: rEEG-guided therapy
- Registration Number
- NCT00437827
- Lead Sponsor
- MYnd Analytics
- 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 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.
- 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 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:
1. 18 years of age or older.
2. Diagnosis of Major Depressive Disorder. Subjects may meet criteria for both melancholic and atypical depression.
3. Have failed 1 or more SSRIs, or have failed 2 or more antidepressants in at least 2 drug classes.
And patients must not have:
1. 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.
2. 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Star*D algorithm 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) 2 rEEG-guided therapy 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.
- Primary Outcome Measures
Name Time Method Two group comparison of QIDS-SR16 and Q-LES-Q-SF after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Two group comparison of MADRS, Clinical Global Improvement and Severity. after 12 weeks of therapy
Trial Locations
- Locations (13)
Hawaii Clinical Research Center
🇺🇸Honolulu, Hawaii, United States
Stanford University
🇺🇸Stanford, California, United States
Harvard Medical School - Cambridge Hospital
🇺🇸Cambridge, Massachusetts, United States
Shanti Research and Clinical Trials
🇺🇸San Bernardino, California, United States
McClean Hospital/Harvard
🇺🇸Belmont, Massachusetts, United States
Elite Clinical Trials
🇺🇸Wildomar, California, United States
Cornell University
🇺🇸New York City, New York, United States
Behavioral Research Specialists
🇺🇸Glendale, California, United States
Alpha Behavioral Care, P.A.
🇺🇸Summit, New Jersey, United States
Rush University
🇺🇸Chicago, Illinois, United States
University of California - Irvine
🇺🇸Irvine, California, United States
Univ of TX Health Science Center
🇺🇸San Antonio, Texas, United States
Radiant Research
🇺🇸Denver, Colorado, United States