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Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS - NCT00887679-27710(Clinical Trial 288907)



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City:  Durham
State:  
NC
Zip Code: 27710
Conditions: Anxiety Disorders - HIV Infections
Purpose: 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.
Study summary: 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.
Criteria: Inclusion Criteria: - age 18 to 65 years, - DSM-IV criteria for Generalized 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 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 opportunistic infection or CNS malignancies 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 for fluoxetine) or antipsychotic or anti-anxiety medications. - In the opinion of the investigator the clinical condition precludes participation in the trial.
Study is available at: Duke University Medical Center
Durham, NC 27710
United States

Primary Contact:
Josephine W Harper, BA
Email: white043@mc.duke.edu
Phone: 9196810613
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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