Brain Activity Changes and Treatment Response in Depressed People Who Are Receiving Antidepressant Medication
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Escitalopram; Sertraline
Intervention type(s): Drug; Drug
Intervention description(s): Level 1 of the study involves open-label treatment with escitalopram, up to 30 mg/day for up to 12 weeks.; Level 2 of the study involves open-label treatment with sertraline, up to 200 mg/day for up to 12 weeks.
Other intervention name(s): Lexapro; Zoloft
Intervention MeSH terms: Sertraline; Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment