Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS - Full Text View

Sponsor:	Duke University
Collaborator:	Forest Laboratories
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00887679

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Anxiety HIV/AIDS

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

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:

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.

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.

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 24, 2012