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

Duke University

Status and phase: Completed; Phase 3

Conditions: HIV Infections; Anxiety Disorders

Treatments: Drug: Escitalopram

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00887679

LXP-MD-0148

Pro00011288

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Escitalopram

Experimental group

Description:

Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Open label, rater-blinded, prospective, 6-week trial of escitalopram.Subjects received escitalopram 10-20mg. Escitalopram was started at 10mg per day and augmented weekly in 10mg per day increments, the maximum dose being 20mg per day.

Treatment:

Drug: Escitalopram