Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/3/2014 |
| Start Date: | May 2009 |
| End Date: | September 2010 |
| Contact: | Josephine W Harper, BA |
| Email: | white043@mc.duke.edu |
| Phone: | 9196810613 |
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.
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.
effective in the treatment of HIV-infected patients with generalized anxiety disorder.
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.
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.
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.
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