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rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure

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ClinicalTrials.gov Identifier: NCT00437827
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : October 27, 2009
Sponsor:
Information provided by:
CNS Response

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Other: Star*D algorithm Other: rEEG-guided therapy Not Applicable

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


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : August 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Two group comparison of QIDS-SR16 and Q-LES-Q-SF [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Two group comparison of MADRS, Clinical Global Improvement and Severity. [ Time Frame: after 12 weeks of therapy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older.
  2. Diagnosis of Major Depressive Disorder validated by SCID. Subjects may meet criteria for both melancholic and atypical depression per this protocol.
  3. 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.
  4. 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:

  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. Participation in any other therapeutic drug study evaluating a treatment for depression within 60 days preceding inclusion, unless drug(s) half-life is known.
  3. Known pregnancy and/or lactation, or intent to become pregnant during this study.

  4. 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by CNS Response:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders