Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Citalopram
Intervention MeSH terms: Citalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: Female
Minimum age: 24 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Studies of the neural mechanisms underlying placebo effects in antidepressant clinical trials
      largely have been limited to demonstrating objective differences in brain activity between
      responders and non-responders to placebo. This 8 week Placebo-controlled and Open groups
      study employs a novel antidepressant trial design with integrated functional magnetic
      resonance imaging (fMRI) to manipulate patient expectancy and examine its neural mediators.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 24-75 years

          -  Diagnosed with Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Major
             Depressive Disorder, nonpsychotic

          -  24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16

          -  Willing to and capable of providing informed consent and complying with study
             procedures

          -  Subjects are right-handed

          -  Using appropriate contraceptive method if woman of child-bearing age

        Exclusion Criteria:

          -  Current comorbid Axis I DSM IV disorder other than Nicotine Dependence, Adjustment
             Disorder, Panic Disorder, Generalized Anxiety Disorder, or Social Phobia

          -  Diagnosis of substance abuse or dependence (excluding Nicotine Dependence) within the
             past 12 months

          -  History of psychosis or psychotic disorder, mania or bipolar disorder

          -  Subject is considered to be at significant risk of suicide based on current mental
             status and recent history

          -  History of allergic or adverse reaction to citalopram, or nonresponse to adequate
             trial of citalopram (at least 4 weeks at dose of 40mg) or escitalopram (at least 4
             weeks at dose of 20mg)

          -  Subject is considered based on history to be unlikely to respond to the single agent
             citalopram (i.e., subjects with treatment resistant depression)

          -  Current treatment with psychotherapy

          -  Clinical Global Impression (CGI)-Severity score of 7 at baseline Clinical Interview

          -  Current or recent (within the past 4 weeks) treatment with any of the following:
             antidepressants, antipsychotics, mood stabilizers, isoniazid, glucocorticoids,
             opiates, centrally active antihypertensive drugs (e.g. clonidine, reserpine)

          -  Subject has metal in body or prior history working with metal fragments (e.g., as a
             machinist), tattoos, or unable to tolerate the scanning procedures (i.e., severe
             obesity, claustrophobia)

          -  Acute, severe, or unstable medical illness