Charles DeBattista
rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study is testing a process for selecting the most appropriate medication(s) to treat a patient's depression (rEEG) versus a control group being treated according to a standardized method, the 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.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Procedure: rEEG guided therapy
- Procedure: Star D Algorithm
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. 18 years of age or older who speak and read English.
2. Diagnosis of Major Depressive Disorder validated by MINI.
3. Have failed 1 or more SSRI treatments during the current episode and not have been treated with another psychotropic class of medications for depression at any time in the past, for the Stratum Leg A. For Stratum Leg B, inclusion consists of 2 or more antidepressants of at least 2 classes during the current episode. Those subjects in the Stratum Leg B will enter the algorithm at Star*D Step 2 minimum. Any previous psychotropic medications outside of the current episode will be documented for both Legs.
4. Able to stop all medications for 5 half-lives of the medication(s), with the exception for hormonal replacement therapies such as thyroxine, insulin, and oral contraceptives, and hydrochlorothiazide or any other medicines determined by CNS Response not to lead to the possibility of altering the rEEG results. Drugs of abuse must be stopped for 7 half-lives.
Key Exclusion Criteria:
Exclusion criteria
1. History of: closed head injury with unconsciousness, craniotomy, cerebral metastases, cerebrovascular acccident; current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
2. Recent history of or current substance abuse.
3. Clinically significant medical illness, including any thyroid disorders.
4. Participation in any other therapeutic drug study evaluating a treatment for depression within 60 days preceding inclusion, unless drug(s) half-life is known.
5. Known pregnancy and/or lactation, or intent to become pregnant during this study.
6. Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
7. 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 or previous failure of medications recommended
Additional Study Details
Official Title:
A Multicenter, Randomized, Blinded, Controlled, Parallel Group Trial to Demonstrate the Efficacy of rEEG Guided Pharmacotherapy of Subjects With Depression Treatment FailureAnticipated start date:
9/1/2006Lead Sponsor:
CNS ResponseInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Single BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Outcomes will be measured by assessment of Quality of Life and self ratings of depression assessed by the Q-LES-Q-SF and QIDS-SR16
Secondary Outcomes:
- Two group comparison of QUIDS and Q-LES-Q self rating scores.
- MADRS and CGI.
- MADRS and CGI.
Total Number to be Enrolled:
120Total Number to be Enrolled at Stanford:
25More Information
Secondary ID(s):
- CNSR #010
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/7/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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