Clinical trial NCT01797380: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Depression
HIV
Keywords: Depression
HIV
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction in Depressive Symptoms
timeFrame: 9 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
citation: 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.
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. doi: 10.1176/appi.psy.45.3.210.
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. doi: 10.1016/s0149-2918(03)80076-0.
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. doi: 10.1089/apc.2005.19.813.