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

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ClinicalTrials.gov Identifier: NCT01797380
Recruitment Status : Terminated (Failure to recruit.)
First Posted : February 22, 2013
Results First Posted : May 16, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE February 20, 2013
First Posted Date  ICMJE February 22, 2013
Results First Submitted Date  ICMJE February 25, 2013
Results First Posted Date  ICMJE May 16, 2013
Last Update Posted Date May 27, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Reduction in Depressive Symptoms [ Time Frame: 9 weeks. ]
Depressive symptoms were assessed by questionaire at baseline then finally at the end of the study at 9 weeks.
Change History Complete list of historical versions of study NCT01797380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women
Official Title  ICMJE A Double-Blind, Placebo-Controlled Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • HIV
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Sugar Pill
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Active Drug
    Escitalopram tablet, 10mg, daily, 9 weeks.
    Intervention: Drug: Escitalopram
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 21, 2013)
5
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01797380
Other Study ID Numbers  ICMJE Pro00000703
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date March 2013

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