Official Title: “Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder, Adherence to Antiretroviral Therapy,Cognition, and Immune Status Among Patients With HIV and AIDS: A 6-Week Open-Label, Prospective, Pilot Trial.”

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 Type: Interventional

Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • 10-20 mg/day oral of Escitalopram for 6-weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Escitalopram
  • Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.

Primary Measures

• Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)
  • Time Frame: 7 weeks
    Safety Issue?: No

Secondary Measures

• Scores on Beck Anxiety & Depression Inventory,CGI severity,CGI improvement,Mini Mental Status examination,Hopkins Verbal Learning,Brief Visual-spatial Memory and Trail Making tests,Sheehan Disability Scores,viral load,CD4 count.
  • Time Frame: 7 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duke University

Overall Clinical Trial Officials and Contacts

Ashwin A Patkar, MD Principal Investigator Duke University  

Overall Contact: Josephine W Harper, BA 9196810613 white043@mc.duke.edu

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00887679

Study ID Number: LXP-MD-0148

ClinicalTrials.gov Identifier: NCT00887679

Health Authority: United States: Institutional Review Board