Clinical trial NCT00437827: rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Keywords: Depression
Lead sponsor: MYnd Analytics
Sponsor class: INDUSTRY
First posted: 2007-02-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Two group comparison of QIDS-SR16 and Q-LES-Q-SF
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Two group comparison of MADRS, Clinical Global Improvement and Severity.
timeFrame: after 12 weeks of therapy
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Behavioral Research Specialists
state: California
city: Irvine
country: United States
facility: University of California - Irvine
state: California
city: San Bernardino
country: United States
facility: Shanti Research and Clinical Trials
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials
state: California
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Honolulu
country: United States
facility: Hawaii Clinical Research Center
state: Hawaii
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Belmont
country: United States
facility: McClean Hospital/Harvard
state: Massachusetts
city: Cambridge
country: United States
facility: Harvard Medical School - Cambridge Hospital
state: Massachusetts
city: Summit
country: United States
facility: Alpha Behavioral Care, P.A.
state: New Jersey
city: New York City
country: United States
facility: Cornell University
state: New York
city: San Antonio
country: United States
facility: Univ of TX Health Science Center
state: Texas
Study officials:
affiliation: Stanford University
name: Charles DeBattista, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cambridge Hospital
name: Gustavo Kinrys, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Steven G Potkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MYnd Analytics
name: Daniel Hoffman, MD
role: STUDY_CHAIR
References: