NCT00375843

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

Response Variability in Treatment Resistant Depression - an Ancillary Study to "Sequenced Treatment Alternatives to Relieve Depression (STAR*D)"

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: National Institute of Mental Health (NIMH) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 behavioral therapies. No single treatment, however, works for everyone. Approximately half of the people being treated for depression do not respond to the first medication they try. Studies have shown that some people with depression show changes in brain activity within 2 weeks of starting treatment, even though symptoms do not change until later. People who do not respond to treatment, however, do not exhibit these changes in brain activity. More information is needed to understand the different ways in which people with depression respond to medication. 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. It will also determine whether the brain testing involved in this study is burdensome to the participants. Individuals interested in taking part in this 1-year study will first attend one screening visit to determine their eligibility for participation. Before beginning treatment, all participants will have an electroencephalogram (EEG) to determine baseline brain activity. Participants will then receive up to 12 weeks of treatment with escitalopram, an antidepressant medication. Study visits will be held every 2 to 3 weeks during this phase. At the Week 2 visit, participants will have another EEG. Participants who respond to escitalopram by the end of the treatment phase will be asked to participate in a 6-month follow-up phase, in which participants will be followed by their own personal physicians, but will have the option to continue treatment with escitalopram. Follow-up visits will be held at Months 3 and 6. Participants who do not respond to escitalopram by the end of the treatment phase will have another EEG, and will then receive up to 12 weeks of treatment with sertraline, another antidepressant medication. Study visits will be held every 2 to 3 weeks, and participants will have a fourth EEG at Week 2. Participants who respond to sertraline will then enter the 6-month follow-up phase, and may continue receiving sertraline. Participants who do not improve with sertraline will receive referrals for additional care outside of the study.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Escitalopram	Level 1 of the study involves open-label treatment with escitalopram, up to 30 mg/day for up to 12 weeks.
DRUG	Sertraline	Level 2 of the study involves open-label treatment with sertraline, up to 200 mg/day for up to 12 weeks.

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-06-01
• Completion: 2008-03-01
• First posted: 2006-09-13
• Last updated: 2013-02-06

Locations

3 sites across 1 country: United States