Personalized Indicators for Predicting Response to SSRI Treatment in Major Depression (The PRISE-MD Study)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Bupropion; Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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