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

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety Disorders; HIV Infections

Intervention: Escitalopram (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Ashwin A Patkar, MD, Principal Investigator, Affiliation: Duke University


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.

Clinical Details

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.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)

Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory

Secondary outcome:

Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)

Change From Randomization to End of Treatment for Trail Making Tet (TMT)

Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)

Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)

Detailed 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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information

Related publications:

Pence BW, Miller WC, Whetten K, Eron JJ, Gaynes BN. Prevalence of DSM-IV-defined mood, anxiety, and substance use disorders in an HIV clinic in the Southeastern United States. J Acquir Immune Defic Syndr. 2006 Jul;42(3):298-306.

Tucker JS, Kanouse DE, Miu A, Koegel P, Sullivan G. HIV risk behaviors and their correlates among HIV-positive adults with serious mental illness. AIDS Behav. 2003 Mar;7(1):29-40.

Starting date: May 2009
Last updated: October 23, 2014

Page last updated: August 23, 2015

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