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Trial record 4 of 44 for:    " January 23, 2013":" February 22, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01797380
Recruitment Status : Terminated (Failure to recruit.)
First Posted : February 22, 2013
Results First Posted : May 16, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To determine the efficacy of escitalopram in treating depression in HIV seropositive women.

Condition or disease Intervention/treatment Phase
Depression HIV Drug: Placebo Drug: Escitalopram Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2008
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Sugar Pill
Placebo
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797380


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

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01797380     History of Changes
Other Study ID Numbers: Pro00000703
First Posted: February 22, 2013    Key Record Dates
Results First Posted: May 16, 2013
Last Update Posted: May 27, 2013
Last Verified: March 2013

Keywords provided by Duke University:
Depression
HIV

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Depression
Fatigue
Behavioral Symptoms
Signs and Symptoms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents