rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437827
• Other study ID #: rEEGTRD010
• Secondary ID: CNSR #010
• Status: Completed
• Phase: N/A
• First received: January 17, 2007
• Last updated: October 23, 2009
• Start date: August 2006
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: CNS Response
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Star*D algorithm
Standard of care based upon the therapies selected in the Star*D study.
• rEEG-guided therapy
An rEEG report is based upon a process that utilizes a patient's drug-free QEEG to predict successful treatment strategies.

Locations

Country	Name	City	State
United States	McClean Hospital/Harvard	Belmont	Massachusetts
United States	Harvard Medical School - Cambridge Hospital	Cambridge	Massachusetts
United States	Rush University	Chicago	Illinois
United States	Radiant Research	Denver	Colorado
United States	Behavioral Research Specialists	Glendale	California
United States	Hawaii Clinical Research Center	Honolulu	Hawaii
United States	University of California - Irvine	Irvine	California
United States	Cornell University	New York City	New York
United States	Univ of TX Health Science Center	San Antonio	Texas
United States	Shanti Research and Clinical Trials	San Bernardino	California
United States	Stanford University	Stanford	California
United States	Alpha Behavioral Care, P.A.	Summit	New Jersey
United States	Elite Clinical Trials	Wildomar	California

Sponsors (1)

Lead Sponsor	Collaborator
CNS Response

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two group comparison of QIDS-SR16 and Q-LES-Q-SF		after 12 weeks of treatment	No
Secondary	Two group comparison of MADRS, Clinical Global Improvement and Severity.		after 12 weeks of therapy	No