rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
This study has been completed.
Sponsor:
CNS Response
Information provided by:
CNS Response
ClinicalTrials.gov Identifier:
NCT00437827
First received: January 17, 2007
Last updated: October 23, 2009
Last verified: October 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depressive Disorder |
Other: Star*D algorithm Other: rEEG-guided therapy |
| Study Type: | Interventional |
| 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 |
Further study details as provided by CNS Response:
Primary Outcome Measures:
- Two group comparison of QIDS-SR16 and Q-LES-Q-SF [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Two group comparison of MADRS, Clinical Global Improvement and Severity. [ Time Frame: after 12 weeks of therapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
Experimental: 2
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
|
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:
- 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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437827
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437827
Locations
| 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 University | |
| Stanford, California, United States, 94305-5401 | |
| Elite Clinical Trials | |
| Wildomar, California, United States, 92595 | |
| United States, Colorado | |
| Radiant Research | |
| Denver, Colorado, United States, 80212 | |
| United States, Hawaii | |
| Hawaii Clinical Research Center | |
| Honolulu, Hawaii, United States, 96826 | |
| United States, Illinois | |
| Rush University | |
| Chicago, Illinois, United States, 60612 / 60076 | |
| United States, Massachusetts | |
| McClean Hospital/Harvard | |
| 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 | |
| Cornell University | |
| New York City, New York, United States, 10021 | |
| United States, Texas | |
| Univ of TX Health Science Center | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
CNS Response
Investigators
| 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 |
More Information
| Responsible Party: | Daniel Hoffman, MD, Chief Medical Officer, CNS Response, Inc. |
| ClinicalTrials.gov Identifier: | NCT00437827 History of Changes |
| Other Study ID Numbers: | rEEGTRD010 CNSR #010 |
| Study First Received: | January 17, 2007 |
| Last Updated: | October 23, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by CNS Response:
|
Depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 23, 2016