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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Forest Laboratories
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• age 18 to 65 years,

• DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) 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 (central nervous system) 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.