Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram
Condition: Depression
MeSH terms: Depressive Disorder
Intervention: Escitalopram
Intervention description: Escitalopram 10 to 30 mg per day for 12 weeks
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Brain Bioenergetic Metabolism; Magnetic Resonance Spectroscopy; Major Depressive Disorder; Treatment Response

Summary:

      This study will evaluate changes in brain energy metabolism due to treatment with
      escitalopram in people with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

        For depressed subjects:

          -  Meets DSM-IV diagnostic criteria for major depressive disorder

          -  Score of greater than 16 on the Hamilton Depression Rating scale (17 items) at study
             entry

          -  Agrees to use an effective form of contraception throughout the study

        For healthy volunteers:

          -  Not currently taking any medications

          -  No lifetime history of major neurological, medical, psychiatric disorder, or head
             injury

          -  Agrees to use an effective form of contraception throughout the study

        Exclusion Criteria:

          -  Current suicidal ideation that may make study participation unsafe

          -  Current serious or unstable medical illness (e.g., cardiovascular, kidney, liver,
             respiratory, endocrine, neurologic, or blood-related disease)

          -  History of seizure disorder

          -  History of or current DSM-IV diagnosis of any of the following psychiatric illnesses
             within 12 months of study entry: organic mental disorder, schizophrenia,
             schizoaffective disorder, delusional disorder, psychotic disorders not otherwise
             specified, bipolar disorder, mood congruent or mood incongruent psychotic features,
             substance dependence disorders (including alcohol)

          -  History of or current diagnosis of dementia, or a score of less than 26 on the Mini
             Mental Status Examination at screening

          -  History of multiple adverse drug reactions or allergic reaction to the study drugs

          -  Currently taking psychotropic drugs or antidepressant medications

          -  Clinical or laboratory evidence of hypothyroidism

          -  Failure to respond during current major depressive episode to at least one adequate
             antidepressant trial, defined as 6 weeks or more of treatment with 40 mg of citalopram
             per day (or its antidepressant equivalent)

          -  History of electroconvulsive therapy (ECT) within the 6 months prior to study entry

          -  Pregnant

          -  Subjects with a CGI score a 6 ("severely depressed") or 7 ("among the most extremely
             depressed patients")

          -  A BMI of 39 or greater, for comfort in scanner