Brain Imaging Techniques That Predict Antidepressant Responsiveness
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Do functional brain changes occur during Venlafaxine ER (extended release) versus Fluoxetine
      treatment and do changes in selective structures, such as the amygdala, predict treatment
      response?
    

Detailed description: 
      This is a single site, controlled, double-blind study of outpatients. There are two arms:

        1. Forty participants who have a current Diagnostic and Statistical Manual of Mental
           Disorders, 4th edition, text revised (DSM-IV-TR) diagnosis of Major Depression will be
           recruited. These subjects will be randomized to receive one of two antidepressant
           medications: Fluoxetine or Venlafaxine ER for the duration of the study. Subjects will
           gradually be titrated onto the medications and will be seen in the clinic up to 18 times
           for medication checks, to monitor side effects and depressive symptoms, including
           suicidal ideation. In the event of suicidal ideation, subjects will be withdrawn from
           the study and referred for immediate treatment.

        2. Twenty normal control subjects with no current or past DSM-IV-TR diagnosis and will
           receive no medication. Normal control subjects will have up to 5 visits while in the
           study.

      Subjects will contact study staff to complete a phone screen and then eligible subjects will
      complete a clinic screen. Subjects will then be scheduled to attend the magnetic resonance
      imaging (MRI) simulation visit and if subjects continue to meet entrance criteria, they will
      be scheduled for the first MRI. Following the first MRI, subjects in the medication
      conditions will begin receiving medication.

      All subjects will undergo 3 functional magnetic resonance imaging (fMRI)s during the study:
      at the beginning of the study, approximately 8 weeks and 26 weeks later. During the MRI,
      subjects will view slides with positive and negative emotional content. Subjects will
      complete various clinical interviews or rating scales assessing mood and side effects at each
      of the visits.
    

Intervention name(s): Venlafaxine ERT; Fluoxetine
Intervention type(s): Drug; Drug
Intervention description(s): Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d.; Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d
Other intervention name(s): Effexor ER; Prozac
Intervention MeSH terms: Fluoxetine; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Major Depressive Disorder