rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure

NCT00437827 | Completed

• 2 other identifiers: rEEGTRD010CNSR #010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 13

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.

Conditions

Depressive Disorder

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Two group comparison of QIDS-SR16 and Q-LES-Q-SF

  after 12 weeks of treatment

Secondary Outcomes (1)

• Two group comparison of MADRS, Clinical Global Improvement and Severity.

  after 12 weeks of therapy

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

EXPERIMENTAL

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

Interventions

Star*D algorithm OTHER

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

Also known as: Standard of Care

1

rEEG-guided therapy OTHER

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

Also known as: EEG-based technology

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Diagnosis of Major Depressive Disorder validated by SCID. Subjects may meet criteria for both melancholic and atypical depression per this protocol.
• 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.
• 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.

You may not qualify if:

• 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.
• Known pregnancy and/or lactation, or intent to become pregnant during this study.
• 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

Sponsors & Collaborators

• MYnd Analytics: lead

Study Sites (13)

Behavioral Research Specialists

Glendale, California, 91204, United States

Location

University of California - Irvine

Irvine, California, 92868, United States

Location

Shanti Research and Clinical Trials

San Bernardino, California, 92324, United States

Location

Stanford University

Stanford, California, 94305-5401, United States

Location

Elite Clinical Trials

Wildomar, California, 92595, United States

Location

Radiant Research

Denver, Colorado, 80212, United States

Location

Hawaii Clinical Research Center

Honolulu, Hawaii, 96826, United States

Location

Rush University

Chicago, Illinois, 60612 / 60076, United States

Location

McClean Hospital/Harvard

Belmont, Massachusetts, 02478-9106, United States

Location

Harvard Medical School - Cambridge Hospital

Cambridge, Massachusetts, 02139, United States

Location

Alpha Behavioral Care, P.A.

Summit, New Jersey, 07901, United States

Location

Cornell University

New York, New York, 10021, United States

Location

Univ of TX Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Charles DeBattista, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Gustavo Kinrys, M.D.

  Cambridge Hospital

  PRINCIPAL INVESTIGATOR

• Steven G Potkin, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Daniel Hoffman, MD

  MYnd Analytics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: February 21, 2007
• Study Start: August 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 27, 2009

Record last verified: 2009-10

Locations

US (13)