Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      Our goals are 1) to use functional magnetic resonance imaging (fMRI) to predict which
      depressed individuals will respond to different validated treatments for unipolar depression
      including Cognitive Therapy (CT) and antidepressant medications (selective serotonin reuptake
      inhibitors; SSRIs) and 2) to understand whether CT and SSRIs affect similar aspects of brain
      function underlying cognition and emotion. Thus, we will examine depressed adults ages 18-55
      using fMRI during cognitive and emotional information processing tasks, before and after
      treatment with an SSRI (n=25) or CT (n=40). We hypothesize that: 1) Recovery will occur in
      treatment with an SSRI primarily for individuals with increased reactivity in limbic brain
      regions associated with emotion generation and prefrontal regions associated with
      regulation,. 2) Recovery with CT will occur for patients with increased activity in brain
      regions associated with emotion generation but decreased activity in prefrontal regions
      associated with emotion regulation. 3) Recovery with an SSRI will yield similar changes in
      brain function to CT in brain regions associated with emotion generation but less change in
      brain regions responsible for emotion regulation such as the prefrontal cortex. Findings from
      this study may have a profound impact on reducing the burden of clinical depression by
      providing evidenced-based diagnostic and treatment guidelines.
    

Detailed description: 
      Same as above.
    

Intervention name(s): SSRI; CBT
Intervention type(s): Drug; Behavioral
Intervention description(s): SSRI: 25 patients will receive 14 weeks of an FDA approved selective serotonin reuptake inhibitor (SSRI), administered under the supervision of a staff psychiatrist. After an initial 30-45 minute session patients will be seen for 15-30 minute sessions for 16-20 sessions over 14 weeks. Medication will begin with 10mg escitalopram daily (or its equivalent), increased to 30 mg/day (or its equivalent) by week 6 if pt has not achieved a minimum level of response (i.e., CGI < 2) and tolerability is adequate. Nonresponse at week 10 (CGI < 2) will be cause for medication switch or augmentation.; Cognitive Behavior Therapy: 40 patients will receive 16- 20 60 minute sessions of procedurally determined Cognitive Therapy (Beck, 1979) over 14 weeks. Patients will begin with 2 sessions per week which may be reduced to once per week in the latter part of the study period if the patient is responding to the therapy. Cognitive Therapy is designed to teach skills that help to reduce depressive severity. Each session will be videotaped and will include homework to be completed and brought to the following session.
Other intervention name(s): Lexapro; escitalopram; Prozac; fluoxetine; Sertraline; Zoloft; CT; Cognitive Therapy
Intervention MeSH terms: Fluoxetine; Sertraline; Escitalopram
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Selective Serotonin Reuptake Inhibitors; Cognitive Behavior Therapy; Cognitive Therapy; antidepressant medications