Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00437827
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : October 27, 2009
Sponsor:
Information provided by:
MYnd Analytics

Tracking Information
First Submitted Date  ICMJE January 17, 2007
First Posted Date  ICMJE February 21, 2007
Last Update Posted Date October 27, 2009
Study Start Date  ICMJE August 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2007)
Two group comparison of QIDS-SR16 and Q-LES-Q-SF [ Time Frame: after 12 weeks of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
Two group comparison of HAM-D, MADRAS, and CGI scores
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2007)
Two group comparison of MADRS, Clinical Global Improvement and Severity. [ Time Frame: after 12 weeks of therapy ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
Two group comparison of QUIDS and Q-LES-Q self rating scores.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
Official Title  ICMJE A Multicenter, Randomized, Blinded, Controlled, Parallel Group Trial to Demonstrate the Efficacy of rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder
Intervention  ICMJE
  • Other: Star*D algorithm
    Standard of care based upon the therapies selected in the Star*D study.
    Other Name: Standard of Care
  • 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
Study Arms  ICMJE
  • 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)
    Intervention: Other: Star*D algorithm
  • 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.
    Intervention: Other: rEEG-guided therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 27, 2007)
120
Original Enrollment  ICMJE
 (submitted: February 20, 2007)
25
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00437827
Other Study ID Numbers  ICMJE rEEGTRD010
CNSR #010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Hoffman, MD, Chief Medical Officer, CNS Response, Inc.
Study Sponsor  ICMJE MYnd Analytics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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 MYnd Analytics
PRS Account MYnd Analytics
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP