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

This study has been terminated.
(Failure to recruit.)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
First received: February 20, 2013
Last updated: May 17, 2013
Last verified: March 2013
To determine the efficacy of escitalopram in treating depression in HIV seropositive women.

Condition Intervention Phase
Drug: Placebo
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Reduction in Depressive Symptoms [ Time Frame: 9 weeks. ] [ Designated as safety issue: No ]
    Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.

Enrollment: 5
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
Drug: Placebo
Placebo daily for duration of double-blind portion of trial
Active Comparator: Active Drug
Escitalopram tablet, 10mg, daily, 9 weeks.
Drug: Escitalopram
Escitalopram 10 mg po daily for duration of double-blind portion of trial

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797380

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01797380     History of Changes
Other Study ID Numbers: Pro00000703 
Study First Received: February 20, 2013
Results First Received: February 25, 2013
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016