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

Completed · Phase 4

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00917059

Run by

University of California, Los Angeles

People needed

172

Starts

2009-05-01

Expected to finish

2012-05-01

Last updated by the study team

2013-02-06

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• UCLA Semel Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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