rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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

MYnd Analytics

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; MYnd Analytics

More Information

• Responsible Party: Daniel Hoffman, MD, Chief Medical Officer, CNS Response, Inc.
• ClinicalTrials.gov Identifier: NCT00437827
• Other Study ID Numbers: rEEGTRD010; CNSR #010
• First Posted: February 21, 2007
• Last Update Posted: October 27, 2009
• Last Verified: October 2009

Keywords provided by MYnd Analytics:

Depression

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders