Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
Information source: Duke University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorders; HIV Infections
Intervention: Escitalopram (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Ashwin A Patkar, MD, Principal Investigator, Affiliation: Duke University
Overall contact:
Josephine W Harper, BA, Phone: 9196810613, Email: white043@mc.duke.edu
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.
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: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Josephine W Harper, BA, Phone: 9196810613, Email: white043@mc.duke.edu
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
Ending date: September 2010
Last updated: May 14, 2009
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