Status:
COMPLETED
Brain Activity Changes and Treatment Response in Depressed People Who Are Receiving Antidepressant Medication
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study will examine how brain activity is affected by antidepressant treatment and how changes in brain activity relate to treatment response in people with depression.
Detailed Description
Depression is a serious medical illness that is characterized by a persistent sad, anxious, or empty mood. Many treatments have been shown to relieve depression, including both medications and behavio...
Eligibility Criteria
Inclusion
- Currently an outpatient with nonpsychotic, unipolar major depressive disorder (MDD)
- Score of 14 or greater on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
- Antidepressant treatment is deemed appropriate by the study clinician
- Willing to use an effective form of contraception throughout the study
Exclusion
- Mentally or legally incapacitated
- Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, MDD with psychotic features, or dementia
- Patients currently suffering from anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder
- History of substance abuse disorder within 6 months prior to study entry
- Current suicidal ideation that would make outpatient treatment unsafe
- Past medication response that may make escitalopram or sertraline treatment unsafe or inappropriate (e.g., previous intolerance or lack of response to either medication)
- History of a failed treatment with escitalopram (40 mg or more) or sertraline (200 mg or more) during the current depressive episode
- Any medical conditions that would make treatment with escitalopram or sertraline medically inadvisable
- Unstable medical illness
- Unstable psychiatric illness likely to require inpatient treatment within the 6 months following study entry
- History of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal EEG
- Pregnant or plans to become pregnant within the 12 months following study entry
- Breastfeeding
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00375843
Start Date
January 1 2005
End Date
March 1 2008
Last Update
February 6 2013
Active Locations (3)
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1
UCLA Semel Institute
Los Angeles, California, United States, 90095
2
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
3
Harvard/MGH
Boston, Massachusetts, United States, 02114