A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women

Study Overview
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Brief Summary
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To determine the efficacy of escitalopram in treating depression in HIV seropositive women.

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

Official Title
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A Double-Blind, Placebo-Controlled Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women

Conditions
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HIV, Depression

Intervention / Treatment
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* Drug: Placebo
* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar Pill<br>Placebo | Drug: Placebo<br>* Placebo daily for duration of double-blind portion of trial<br>|
| Active Comparator: Active Drug<br>Escitalopram tablet, 10mg, daily, 9 weeks. | Drug: Escitalopram<br>* Escitalopram 10 mg po daily for duration of double-blind portion of trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Depressive Symptoms | Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks. | 9 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Depression