rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure

October 23, 2009 updated by: MYnd Analytics

A Multicenter, Randomized, Blinded, Controlled, Parallel Group Trial to Demonstrate the Efficacy of rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91204
        • Behavioral Research Specialists
      • Irvine, California, United States, 92868
        • University of California - Irvine
      • San Bernardino, California, United States, 92324
        • Shanti Research and Clinical Trials
      • Stanford, California, United States, 94305-5401
        • Stanford University
      • Wildomar, California, United States, 92595
        • Elite Clinical Trials
    • Colorado
      • Denver, Colorado, United States, 80212
        • Radiant Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Hawaii Clinical Research Center
    • Illinois
      • Chicago, Illinois, United States, 60612 / 60076
        • Rush University
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478-9106
        • McClean Hospital/Harvard
      • Cambridge, Massachusetts, United States, 02139
        • Harvard Medical School - Cambridge Hospital
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Alpha Behavioral Care, P.A.
    • New York
      • New York City, New York, United States, 10021
        • Cornell University
    • Texas
      • San Antonio, Texas, United States, 78229
        • Univ of TX Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • EEG-based technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Two group comparison of QIDS-SR16 and Q-LES-Q-SF
Time Frame: after 12 weeks of treatment
after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Two group comparison of MADRS, Clinical Global Improvement and Severity.
Time Frame: after 12 weeks of therapy
after 12 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MYnd Analytics

Investigators

  • Principal Investigator: Steven G Potkin, MD, University of California, Irvine
  • Principal Investigator: Charles Debattista, MD, Stanford University
  • Principal Investigator: Gustavo Kinrys, M.D., Cambridge Hospital
  • Study Chair: Daniel Hoffman, MD, MYnd Analytics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Estimate)

October 27, 2009

Last Update Submitted That Met QC Criteria

October 23, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rEEGTRD010
  • CNSR #010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depressive Disorder

Clinical Trials on Star*D algorithm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe