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

May 17, 2013 updated by: Duke University

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Estimate)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00000703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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