Identifying Factors That Predict Antidepressant Treatment Response
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study will compare different treatments for depression in order to identify which
      factors predict effectiveness, and will include a companion study which investigates
      combining treatments and long term effectiveness.
    

Detailed description: 
      Major depressive disorder (MDD) is a serious illness that affects a person's body, mood, and
      thoughts. The symptoms of MDD can interfere with a person's ability to work, study, sleep,
      eat, and enjoy activities that were once pleasurable. Antidepressant medications and
      psychotherapy are among the effective treatments for MDD. Individuals often respond to one
      type of treatment, but not another. Currently, however, doctors have no way of
      pre-determining which individuals will most benefit from which treatments. In the absence of
      practical predictors of MDD treatment response, the potential efficacy of existing MDD
      treatments is limited. This study will identify factors that may predict MDD treatment
      response by comparing the effectiveness of a selective serotonin reuptake inhibitor (SSRI), a
      serotonin norepinephrine reuptake inhibitor (SNRI), and cognitive behavioral therapy in
      people with MDD.

      Participants in this 14-week, double-blind study will be randomly assigned to receive
      duloxetine (SNRI), escitalopram (SSRI), or cognitive behavioral therapy. During the first 2
      weeks of screening, participants will complete questionnaires, clinician evaluations, an
      electrocardiogram, a personality assessment, a dexamethasone-corticotropin releasing factor
      test, a functional magnetic resonance imaging scan and provide blood samples. Upon completion
      of screening, patients will start the treatment to which they were randomized. Duloxetine and
      escitalopram are two medications that are approved by the Food and Drug Administration for
      the treatment of depression. Cognitive behavioral therapy is a talking therapy that is also
      used to treat depression. All participants assigned to take duloxetine or escitalopram will
      be seen by a study physician weekly for 6 weeks, and then every other week for the remainder
      of the study. Participants assigned to cognitive behavioral therapy will attend therapy
      sessions twice a week for the first 4 weeks, and then once a week for the remainder of the
      study. The following assessments will be performed for all participants at each visit: vital
      sign and weight measurements; clinician assessments; and self-report questionnaires.
      Additionally, blood samples will be taken at three visits through the trial and functional
      magnetic resonance imaging (fMRI) scans will be performed at selected times.

      A companion study to the main CIDAR study offers participants further treatment. Participants
      who achieve remission after the initial 12 weeks of treatment will have the option to enroll
      in a 21-month follow-up study of maintenance treatment, with visits every three months to
      monitor for sustained response and relapse. Participants who do not remit will have the
      option to enroll in another 12-week treatment course, receiving a combination of CBT and
      medication. Participants who achieve response after this combination treatment will be
      eligible to receive maintenance combination treatment for up to an additional 18 months,
      monitored for sustained response and relapse. Participants who do not wish to enroll or
      continue in the companion study will be provided with a referral for treatment with another
      mental health provider.
    

Intervention name(s): Escitalopram; Duloxetine; Cognitive behavioral therapy (CBT)
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Escitalopram 10 to 20 mg per day for 12 weeks; Duloxetine 30 to 60 mg per day for 12 weeks; CBT will include 16 one-hour sessions provided over 12 weeks.
Other intervention name(s): Lexapro; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Escitalopram; Duloxetine; Cognitive Behavioral Therapy; PET; fMRI