Personalized Indicators for Predicting Response to SSRI Treatment in Major Depression (The PRISE-MD Study)
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      Major depressive disorder (MDD) is a common psychiatric illness with a high cost to society
      and individual patients. Initial medication treatments for MDD are often ineffective,
      precipitating a need to try other medications. This extends suffering, continues functional
      disability, and increases both the risk of relapse and the risk that people will abandon
      treatment. Having a biological marker of likely treatment effectiveness to predict and guide
      clinicians' decisions would reduce the likelihood of people with MDD experiencing
      unsuccessful treatments. This study will test whether quantitative electroencephalogram
      (QEEG) measures taken after 1 week of medication treatment can predict effectiveness of a
      full treatment regimen with depression medications.

      Participation in this study will last 8 weeks. At the first study visit, participants will
      undergo baseline assessments. These assessments will include an interview about present
      condition, medical and psychiatric history, and past and current medication treatments; a
      urine test; and questionnaires about depression symptoms and other possible symptoms. The
      study doctor may ask for other assessments based on each participant's individual profile.

      Participants will then complete a 1-week treatment with escitalopram, a type of
      antidepressant medication called a selective serotonin reuptake inhibitor (SSRI). At the
      first visit and again after the week-long escitalopram treatment, participants will undergo
      an electroencephalogram (EEG), which measures brain electrical activity. Based on certain
      measurements obtained from the EEG, an antidepressant treatment response (ATR) score will be
      calculated.

      Participants will then be divided into two treatment groups: those who continue to receive
      escitalopram and those who begin treatment with bupropion XL, a non-SSRI antidepressant
      medication. Treatment for both groups will last 8 weeks, during which time participants will
      attend seven study visits. At these study visits, participants will be asked about how they
      are feeling, side effects, and benefit from the treatment. Further tests-such as a physical
      exam, lab test, or EEG-may be performed if study doctors think they are necessary.
    

Intervention name(s): Escitalopram; Bupropion XL
Intervention type(s): Drug; Drug
Intervention description(s): Fixed dose of 10 mg per day; Fixed dose of 150 mg per day
Other intervention name(s): Lexapro; Wellbutrin XL
Intervention MeSH terms: Bupropion; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; SSRI; EEG