Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
Recruitment status was Not yet recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||September 2010|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
10-20 mg/day oral of Escitalopram for 6-weeks
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.
|Contact: Josephine W Harper, BAfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator: Ashwin A Patkar, MD|
|Principal Investigator:||Ashwin A Patkar, MD||Duke University|