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

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

Tracking Information

• First Submitted Date: February 20, 2013
• First Posted Date: February 22, 2013
• Results First Submitted Date: February 25, 2013
• Results First Posted Date: May 16, 2013
• Last Update Posted Date: May 27, 2013
• Study Start Date: January 2008
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Depression
• HIV

Intervention

• 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

• Placebo Comparator: Sugar Pill
  Placebo
  Intervention: Drug: Placebo
• Active Comparator: Active Drug
  Escitalopram tablet, 10mg, daily, 9 weeks.
  Intervention: Drug: Escitalopram

Publications *

• Barroso J. A review of fatigue in people with HIV infection. J Assoc Nurses AIDS Care. 1999 Sep-Oct;10(5):42-9. Review.
• Currier MB, Molina G, Kato M. Citalopram treatment of major depressive disorder in Hispanic HIV and AIDS patients: a prospective study. Psychosomatics. 2004 May-Jun;45(3):210-6.
• Gutierrez MM, Rosenberg J, Abramowitz W. An evaluation of the potential for pharmacokinetic interaction between escitalopram and the cytochrome P450 3A4 inhibitor ritonavir. Clin Ther. 2003 Apr;25(4):1200-10.
• Himelhoch S, Medoff DR. Efficacy of antidepressant medication among HIV-positive individuals with depression: a systematic review and meta-analysis. AIDS Patient Care STDS. 2005 Dec;19(12):813-22. Review.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 21, 2013): 5
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2009
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01797380
• Other Study ID Numbers: Pro00000703
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Duke University
• Study Sponsor: Duke University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Duke University
• Verification Date: March 2013