Status:
COMPLETED
Personalized Indicators for Predicting Response to SSRI Treatment in Major Depression (The PRISE-MD Study)
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
21-75 years
Phase:
PHASE4
Brief Summary
This study will examine whether measures of brain electrical signals taken after a week of antidepressant medication treatment can predict whether a full treatment regimen will be effective.
Detailed Description
Major depressive disorder (MDD) is a common psychiatric illness with a high cost to society and individual patients. Initial medication treatments for MDD are often ineffective, precipitating a need t...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for diagnosis of major depressive disorder (MDD) based on the Mini-International Neuropsychiatric Interview (MINI)
- Score greater than or equal to 12 on the Quick Inventory of Depressive Symptomatology - Self Rated version (QIDS-SR16)
Exclusion
- Serious or unstable medical illness that would prevent complete participation in the trial, determined as needed from physical examination, electrocardiogram (ECG), laboratory safety tests, and review of systems
- Mentally or legally incapacitated and therefore unable to give informed consent
- Meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features
- Diagnosis of a DSM-IV axis II disorder that would interfere with completion of the protocol
- Would have met criteria for a diagnosis of drug dependency or substance abuse within the preceding 9 months
- Stable and in remission on current psychotropic medication(s)
- Has had a course of electroconvulsive therapy (ECT) within the past 6 months
- Started psychotherapy for the current depressive episode within the past 2 months
- Has experienced treatment failure with an adequate trial of any study medication during the current episode of depression or has failed to tolerate escitalopram in the current episode
- Known contraindication for use of any of the study drugs, including hyponatremia during past use of a selective serotonin reuptake inhibitor (SSRI)
- Treated with fluoxetine or a monoamine oxidase inhibitor (MAOI) within the past 4 weeks
- Presence of a serious or unstable medical illness, including heart, liver, kidney, respiratory, endocrine, neurologic, or blood disease severe enough to significantly affect brain function or to interfere with interpretation of study results
- History of seizures, brain surgery, skull fracture, significant head trauma, or abnormal electroencephalogram (EEG)
- Currently pregnant or of childbearing potential and not using a medically acceptable means of birth control (e.g., oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device \[IUD\], past tubal ligation, partner with vasectomy)
- Breastfeeding
- University student or staff member directly under instruction, supervision, or employment of any of the investigators
- Requires hospitalization (e.g., poses an imminent danger to self or others)
- Initial quantitative EEG (QEEG) is contaminated with artifact so that determination of the biomarker is precluded
- Use of medications known to affect brain function
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00917059
Start Date
May 1 2009
End Date
May 1 2012
Last Update
February 6 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Semel Institute
Los Angeles, California, United States, 90095