Status:
COMPLETED
Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to try to see if antidepressant medications cause changes in QEEG measurements in the brain. QEEG is a mathematical analysis of electrical currents in the brain using elect...
Detailed Description
Despite the availability of effective clinical treatments for major depressive disorder (MDD), 30-40% of subjects with MDD still fail to respond significantly to antidepressant treatment (Fava and Dav...
Eligibility Criteria
Inclusion
- DSM-IV diagnostic criteria for MDD
- Written informed consent
- Men or women aged 18-65
- A baseline Hamilton-D17 score of \> 16 at screen visit
Exclusion
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
- Known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematological disease
- History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
- History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
- History of multiple adverse drug reactions
- Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants. Concomitant use of antihistamine drugs will be allowed.
- Patients who have failed to respond during the course of their current major depressive episode to at least two adequate antidepressant trials, or have failed more than one adequate trial with an SSRI antidepressant.
- Electroconvulsive therapy (ECT) within the past 6 months
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00157547
Start Date
April 1 2003
End Date
August 1 2006
Last Update
May 28 2008
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