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

NCT00887679 | Completed Phase 3 Results

• 2 other identifiers: Pro00011288LXP-MD-0148
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Disorders; HIV Infections

Keywords

Escitalopram; Anxiety Disorder; HIV and AIDS; treatment experienced

Outcome Measures

Primary Outcomes (2)

• Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)

  The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured.

  baseline and 7 weeks

• Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory

  Scoring The BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows: (0) I do not feel sad. 1. I feel sad. 2. I am sad all the time and I can't snap out of it. 3. I am so sad or unhappy that I can't stand it. A value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:\[6\] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.

  baseline and 7 weeks

Secondary Outcomes (4)

• Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)

  baseline and 7 weeks

• Change From Randomization to End of Treatment for Trail Making Tet (TMT)

  baseline to 7 weeks

• Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)

  baseline and 7 weeks

• Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)

  baseline and 7 weeks

Study Arms (1)

Escitalopram

EXPERIMENTAL

Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Open label, rater-blinded, prospective, 6-week trial of escitalopram.Subjects received escitalopram 10-20mg. Escitalopram was started at 10mg per day and augmented weekly in 10mg per day increments, the maximum dose being 20mg per day.

Drug: Escitalopram

Interventions

Escitalopram DRUG

10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.

Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• 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. doi: 10.1097/01.qai.0000219773.82055.aa.

  PMID: 16639343 BACKGROUND

• 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. doi: 10.1023/a:1022557222690.

  PMID: 14534388 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Ashwin A Patkar Associate Professor
• Organization: Duke University Medical Center

ashwin.patkar@duke.edu

919-668-3626

Study Officials

• Ashwin A Patkar, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2010
• Last Updated: October 31, 2014
• Results First Posted: March 10, 2014

Record last verified: 2014-03

Locations

US (1)