rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure

NCT ID: NCT00437827

Last Updated: 2009-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-10-31

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

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Star*D algorithm

Intervention Type: OTHER

Standard of care based upon the therapies selected in the Star\*D study.

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.

Group Type: EXPERIMENTAL

rEEG-guided therapy

Intervention Type: OTHER

An rEEG report is based upon a process that utilizes a patient's drug-free QEEG to predict successful treatment strategies.

Interventions

Star*D algorithm

Standard of care based upon the therapies selected in the Star\*D study.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Standard of Care; EEG-based technology

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MYnd Analytics

INDUSTRY

Sponsor Role: lead

Responsible Party

CNS Response, Inc.

Principal Investigators

Charles DeBattista, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Gustavo Kinrys, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cambridge Hospital

Steven G Potkin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Daniel Hoffman, MD

Role: STUDY_CHAIR

MYnd Analytics

Locations

Behavioral Research Specialists

Glendale, California, United States

University of California - Irvine

Irvine, California, United States

Shanti Research and Clinical Trials

San Bernardino, California, United States

Stanford University

Stanford, California, United States

Elite Clinical Trials

Wildomar, California, United States

Radiant Research

Denver, Colorado, United States

Hawaii Clinical Research Center

Honolulu, Hawaii, United States

Rush University

Chicago, Illinois, United States

McClean Hospital/Harvard

Belmont, Massachusetts, United States

Harvard Medical School - Cambridge Hospital

Cambridge, Massachusetts, United States

Alpha Behavioral Care, P.A.

Summit, New Jersey, United States

Cornell University

New York, New York, United States

Univ of TX Health Science Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

CNSR #010

Identifier Type: -

Identifier Source: secondary_id

rEEGTRD010

Identifier Type: -

Identifier Source: org_study_id