Depression Clinical Trial
Official title:
Personalized Response Indicators of SSRI Effectiveness in Major Depression
Verified date | February 2013 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UCLA Semel Institute | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score on Hamilton Depression Rating Scale (HAM-D) | Measured nine times over 8 weeks | No | |
Secondary | Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) | Measured nine times over 8 weeks | No |
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