Clinical trial NCT00887679: Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
HIV Infections
Keywords: Escitalopram
Anxiety Disorder
HIV and AIDS
treatment experienced
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2009-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: baseline and 7 weeks
measure: Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory
timeFrame: baseline and 7 weeks
Secondary outcomes:
measure: Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)
timeFrame: baseline and 7 weeks
measure: Change From Randomization to End of Treatment for Trail Making Tet (TMT)
timeFrame: baseline to 7 weeks
measure: Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)
timeFrame: baseline and 7 weeks
measure: Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)
timeFrame: baseline and 7 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Ashwin A Patkar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.qai.0000219773.82055.aa.
citation: 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. doi: 10.1023/a:1022557222690.