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

Phase 4

Terminated

• Conditions: Depression; HIV
• Interventions: Drug: Placebo; Drug: Escitalopram

• Registration Number: NCT01797380
• Lead Sponsor: Duke University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-22
• Results First Submitted: 2013-02-25
• Status Verified: 2013-03
• Results First Submitted QC: 2013-04-04
• Results First Posted: 2013-05-16
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Placebo	Placebo
Active Drug	Escitalopram	Escitalopram tablet, 10mg, daily, 9 weeks.

Primary Outcome Measures

Name	Time	Method
Reduction in Depressive Symptoms	9 weeks.	Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States