Status:
COMPLETED
Quantitative Electroencephalogram (QEEG) Predictors of Response to Psychotherapy Versus Antidepressant Treatment in Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to find out if a test can predict whether someone with depression will get better with treatment. We also want to find out whether there are changes in the brains...
Detailed Description
To our knowledge, QEEG has not been studied in the prediction of response to CBT, an important and widely used non-pharmacologic approach to treating depression. Establishing QEEG technology as a pred...
Eligibility Criteria
Inclusion
- Subjects will be adults, ages 18 to 75 years.
- Written informed consent
- MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
- 17-item Hamilton Depression Rating Scale (HAM-D-17) score of \> 14 at baseline.
- Subjects who are not currently taking any antidepressant or other psychotropic medications and who have been free of these medications for 4 weeks prior to screening visit.
Exclusion
- Women who are pregnant, lactating, or planning a pregnancy during the study.
- Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
- Any uncontrolled psychiatric disorder.
- Current use of psychotropic medications.
- Psychotic features in the current episode or a history of psychotic features.
- Alcohol or substance abuse or dependence within the past three months.
- History of head trauma or seizure disorder.
- History of intolerance of the study medication.
- Failure to respond to escitalopram up to 20 mg for at least 6 weeks.
- Failure to respond to 2 or more adequate antidepressant trials (6 weeks or longer on a therapeutic dose, equivalent to fluoxetine 40mg) in the current episode.
- Currently enrolled in other depression-focused psychotherapy and unwilling to cease treatment.
- Subjects who, per clinical judgment, are not appropriate candidates for CBT or SSRIs.
- 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 3 months.
- Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D.
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00824044
Start Date
July 1 2008
End Date
March 1 2011
Last Update
January 5 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114