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

This study has been terminated.
(Failure to recruit.)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01797380
First received: February 20, 2013
Last updated: May 17, 2013
Last verified: March 2013

February 20, 2013
May 17, 2013
January 2008
April 2009   (final data collection date for primary outcome measure)
Reduction in Depressive Symptoms [ Time Frame: 9 weeks. ] [ Designated as safety issue: No ]
Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.
Reduction in Depressive Symptoms [ Time Frame: 9 weeks. ] [ Designated as safety issue: No ]
Depressive symptoms were assessed by questionaire at baseline then finally at the end of the study at 9 weeks.
Complete list of historical versions of study NCT01797380 on ClinicalTrials.gov Archive Site
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A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women
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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • HIV
  • Drug: Placebo
    Placebo daily for duration of double-blind portion of trial
  • Drug: Escitalopram
    Escitalopram 10 mg po daily for duration of double-blind portion of trial
  • Placebo Comparator: Sugar Pill
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Active Drug
    Escitalopram tablet, 10mg, daily, 9 weeks.
    Intervention: Drug: Escitalopram

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01797380
Pro00000703
No
Duke University
Duke University
Not Provided
Not Provided
Duke University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP