Phase 3
Completed N=30
Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
Source: ClinicalTrials.gov NCT00887679 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A) — 21.23 scores on an anxiety scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A) |
21.23 | — |
| PRIMARY Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory |
27.8 | — |
| SECONDARY Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I) |
1; 2 | — |
| SECONDARY Change From Randomization to End of Treatment for Trail Making Tet (TMT) |
29.2 | — |
| SECONDARY Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE) |
— | — |
| SECONDARY Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS) |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00887679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.