fMRI Study of Treatment Changes in Major Depression
Condition: Major Depression; Treatment
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT)
      has the same healing effect on the brain for people with depression as traditional
      antidepressants do, and in comparison to healthy controls with no history of depression, to
      find out more about the causes of depression including differences in the extent of problems
      caused by depression. We hypothesize that CBT will have the same healing effect on the brain
      as antidepressants; that differences in brain activations created by the various tasks and
      genetic differences will help us understand differences in the type and severity of symptoms
      among the depressed subjects.
    

Detailed description: 
      The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT)
      has the same healing effect on the brain for people with depression as traditional
      antidepressants do, to find out more about the causes of depression and why people differ in
      the extent of problems caused by depression, and to determine if certain differences in genes
      within populations are related to clinical symptoms.Genes we are examining for this study are
      COMT, BDNF, and 5-HTT long arm and short arm, as well as future genes that may be discovered
      to play a role in depression at a later time, and will be determined by examining saliva and
      blood samples. We are primarily studying depression by functional Magnetic Resonance Imaging
      (fMRI) which allows us to identify certain parts of the brain that show how the brain works
      in controlling negative feelings. Participants will be imaged while performing different
      tasks that are believed to activate emotional circuitry of the brain. Comparisons of
      activation patterns across these tasks will be used to characterize the cognitive mechanisms
      supported by different cortical regions, and to determine patterns of functional brain
      deficits in subjects with depression. Comparisons will also be made between changes that
      occur after treatment with an approved antidepressant and treatment with CBT.
    

Intervention name(s): Sertraline; Cognitive Behavioral Therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): Depressed participants will be randomized to SRT or CBT treatment. For those in the SRT treatment condition, visits will involve dispensing medications, checking for side effects and administering the Hamilton Depression rating scale occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response. Depressed subjects will start their SRT treatment once their first MRI and computer testing sessions are completed.; Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed.
Other intervention name(s): SRT; CBT
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Major Depression; Functional Magnetic Resonance Imaging; Emotional Circuitry; Cognitive Behavioral Therapy