Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS

Last updated: October 23, 2014
Sponsor: Duke University
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Anxiety Disorders

Panic Disorders

Treatment

N/A

Clinical Study ID

NCT00887679
Pro00011288
LXP-MD-0148
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and effective in the treatment of HIV-infected patients with generalized anxiety disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 18 to 65 years,

  • DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria forGeneralized Anxiety Disorder

  • confirmed stable HIV disease and attending a HIV treatment program

  • stable dose of highly active anti-retroviral therapy for a minimum of 4 weeks

  • ability to give informed consent

Exclusion

Exclusion Criteria:

  • bipolar disorders, any psychotic disorder

  • current major depression

  • substance dependence (except nicotine dependence) in the previous 3 months

  • currently suicidal or high suicide risk, serious or unstable medical disorders (e.g.uncontrolled hypertension or diabetes)

  • any hospitalization for HIV-related illness in the previous 3 months

  • any active CNS (central nervous system) CNS opportunistic infection or CNSmalignancies related to HIV

  • current active treatment for opportunistic infections related to HIV

  • any psychotropic drug treatment in the previous 2 weeks before screening

  • history of hypersensitivity to escitalopram and/or citalopram

  • admission BDI 23

  • seizure disorder, traumatic brain injury

  • pregnant, nursing mother or planning to get pregnant.

  • Concomitant mediations: At least 2-week washout of antidepressant (4 weeks forfluoxetine) or antipsychotic or anti-anxiety medications.

  • In the opinion of the investigator the clinical condition precludes participation inthe trial.

Study Design

Total Participants: 30
Study Start date:
May 01, 2009
Estimated Completion Date:
September 30, 2010

Study Description

Anxiety disorders are twice as prevalent among HIV-infected patients as they are in the general population. Approximately 25%-40% of HIV-infected patients have anxiety disorders; Generalized Anxiety Disorder, Panic disorder and post-traumatic Stress Disorder being the most frequent. Non-adherence to anti-retroviral medications is commonly seen in patients with HIV with GAD.The role of specific selective serotonin reuptake (SSRIs) in the treatment of HIV-patients with GAD is unclear. Escitalopram has been used in the treatment of GAD in the general population. It has been shown to be safe in HIV-patients with a tolerable side-effect profile. However, whether it can improve GAD in HIV-infected patients has not yet been investigated.

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

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