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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01797380
• Other study ID #: Pro00000703
• Status: Terminated
• Phase: Phase 4
• First received: February 20, 2013
• Last updated: May 17, 2013
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: March 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• HIV
• HIV Seropositivity

Intervention

Drug:
• Placebo
Placebo daily for duration of double-blind portion of trial
• Escitalopram
Escitalopram 10 mg po daily for duration of double-blind portion of trial

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Barroso J. A review of fatigue in people with HIV infection. J Assoc Nurses AIDS Care. 1999 Sep-Oct;10(5):42-9. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Depressive Symptoms	Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.	9 weeks.	No