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

NCT01797380 | Terminated Phase 4 Results

• 1 other identifier: Pro00000703
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; HIV

Keywords

Depression; HIV

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Active Drug

ACTIVE COMPARATOR

Escitalopram tablet, 10mg, daily, 9 weeks.

Drug: Escitalopram

Interventions

Placebo DRUG

Placebo daily for duration of double-blind portion of trial

Sugar Pill

Escitalopram DRUG

Escitalopram 10 mg po daily for duration of double-blind portion of trial

Active Drug

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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. doi: 10.1016/S1055-3290(06)60342-7.

  PMID: 10491802 BACKGROUND

• 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. doi: 10.1176/appi.psy.45.3.210.

  PMID: 15123845 BACKGROUND

• 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. doi: 10.1016/s0149-2918(03)80076-0.

  PMID: 12809966 BACKGROUND

• 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. doi: 10.1089/apc.2005.19.813.

  PMID: 16375613 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Harold Goforth, M.D.
• Organization: Duke University Health Systems

goforth@ccf.org

216-636-3999

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 22, 2013
• Study Start: January 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 27, 2013
• Results First Posted: May 16, 2013

Record last verified: 2013-03

Locations

US (1)