A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women
Condition: Depression; HIV
MeSH terms: HIV Seropositivity; Depression
Intervention: Placebo; Escitalopram
Intervention description: Placebo daily for duration of double-blind portion of trial; Escitalopram 10 mg po daily for duration of double-blind portion of trial
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Depression; HIV

Summary:

      To determine the efficacy of escitalopram in treating depression in HIV seropositive women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of major depression based on DSM-IV criteria;

          -  age 18-70 years;

          -  Greater than 15 on MADRS for severity of depression;

          -  HIV seropositive;

          -  no new antiviral medications over the past 2 months;

          -  involved in active treatment for HIV disease,

          -  negative serum pregnancy test

          -  Those subjects who are actively being treated for depression but show no improvement
             as defined by self-reported failure to improve with current treatment or residual
             depression as demonstrated by a MADRS of 15 or greater will be asked to participate in
             the study as well.

        Exclusion Criteria:

          -  The presence of an active and significant psychiatric disease other than Major
             Depressive Disorder as diagnosed on MINI in the last 3 months;

          -  meeting DSM-IV criteria for an Axis I disorder within the last three months, or
             meeting criteria for substance abuse within the last 12 months;

          -  current pregnancy or lactation if breast feeding;

          -  history of hypersensitivity, intolerance, or contraindication to LEX;

          -  baseline creatinine of 2.5 or greater;

          -  patients taking anticoagulants;

          -  history of diagnosed gastric or duodenal ulcer;

          -  history within past year of bleeding or clotting diathesis;

          -  lifetime history of myocardial infarction or cerebrovascular accident;

          -  history of surgery within the past 3 months;

          -  inability to follow study procedures or complete the study;

          -  the use of any antidepressant medications within 5 half-lives of randomization;

          -  women of child-bearing potential who will not agree to use approved means of birth
             control during the trial;

          -  other reason that the primary investigator believes that the subject will be unable to
             complete trial or has medical/psychiatric contraindications to the trial.

          -  Individuals who are currently being treated for depression and show significant
             improvements in their depression such that discontinuing their current antidepressant
             therapy would likely have negative clinical consequences will be excluded from
             participating in this study.

          -  Individuals who are or become suicidal will be excluded from this study.