Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Duke University.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Duke University
Collaborator:
Forest Laboratories
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00887679
First received: April 23, 2009
Last updated: May 14, 2009
Last verified: April 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders HIV Infections |
Drug: Escitalopram |
Phase 3 |
| Study Type: | Interventional |
| 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. |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 20 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Escitalopram
Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
|
Drug: Escitalopram
10-20 mg/day oral of Escitalopram for 6-weeks
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887679
Contacts
| Contact: Josephine W Harper, BA | 9196810613 | white043@mc.duke.edu |
Locations
| United States, North Carolina | |
| Duke University Medical Center | Not yet recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: Ashwin A Patkar, MD | |
Sponsors and Collaborators
Duke University
Forest Laboratories
Investigators
| Principal Investigator: | Ashwin A Patkar, MD | Duke University |
More Information
Publications:
| Responsible Party: | Ashwin A Patkar, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00887679 History of Changes |
| Other Study ID Numbers: | LXP-MD-0148, Pro00011288 |
| Study First Received: | April 23, 2009 |
| Last Updated: | May 14, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Escitalopram Anxiety Disorder HIV and AIDS treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Anxiety Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mental Disorders Dexetimide Citalopram |
Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation |
ClinicalTrials.gov processed this record on May 23, 2013