Brain Activity Changes and Treatment Response in Depressed People Who Are Receiving Antidepressant Medication

Completed · Phase 4

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00375843

Run by

National Institute of Mental Health (NIMH)

People needed

118

Starts

2005-01-01

Expected to finish

2008-03-01

Last updated by the study team

2013-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Semel Institute — Los Angeles, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Harvard/MGH — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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