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

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ClinicalTrials.gov Identifier: NCT00887679
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : March 10, 2014
Last Update Posted : October 31, 2014
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 24, 2009
Results First Submitted Date  ICMJE November 19, 2012
Results First Posted Date  ICMJE March 10, 2014
Last Update Posted Date October 31, 2014
Study Start Date  ICMJE May 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: baseline and 7 weeks ]
    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.
  • Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory [ Time Frame: baseline and 7 weeks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 7 weeks ]
Change History Complete list of historical versions of study NCT00887679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I) [ Time Frame: baseline and 7 weeks ]
    Scale for scoring: Clinical Global Impression(CGI-S)
    1. = Normal, no symptoms
    2. = Borderline ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = Most extremely ill
    Clinical Global Impression(CGI-I)-improvement since treatment
    1. very much improved
    2. much improved
    3. minimally improved
    4. no change from baseline
    5. minimally worse
    6. much worse
    7. very much worse
  • Change From Randomization to End of Treatment for Trail Making Tet (TMT) [ Time Frame: baseline to 7 weeks ]
    Trail Making Test (TMT)Results for TMT are reported as the number of seconds required to complete the task. Higher scores reveal greater impairment. Average =29 seconds, Deficient > 78 seconds
  • Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE) [ Time Frame: baseline and 7 weeks ]
    Mini Mental State Examination (MMSE),a low score less than or equal to 23 indicates cognitive impairment and the need for further evaluation; normal cognitive function = 27-30, mild cognitive impairment = 21-26, moderate cognitive impairment = 11-20, and severe cognitive impairment = 0-10. The highest possible score is 30.
  • Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS) [ Time Frame: baseline and 7 weeks ]
    Scoring: Participants rate the extent to which work, social life, and home life are impaired by his or her symptoms. A 10 point scale is used where 0= not impaired and 10 is highly impaired indicating. The three aspects of life can be summed up into a single dimensional measure of global functional impairment that indicates 0= not impaired and 30 = highly impaired. Scores of 5 or greater are on any of the three scales are considered significant.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
Official Title  ICMJE 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.
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety Disorders
  • HIV Infections
Intervention  ICMJE Drug: Escitalopram
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.
Study Arms  ICMJE Experimental: Escitalopram
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.
Intervention: Drug: Escitalopram
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2009)
20
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00887679
Other Study ID Numbers  ICMJE Pro00011288
LXP-MD-0148
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Ashwin A Patkar, MD Duke University
PRS Account Duke University
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP