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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00887679
First received: April 23, 2009
Last updated: October 23, 2014
Last verified: March 2014
Results First Received: November 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anxiety Disorders
HIV Infections
Intervention: Drug: Escitalopram

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Anxiety disorders in HIV-infected patients from the general population

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
none

Reporting Groups
  Description
Escitalopram Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.

Participant Flow:   Overall Study
    Escitalopram  
STARTED     30  
COMPLETED     20 [1]
NOT COMPLETED     10  
Withdrawal by Subject                 1  
Lost to Follow-up                 4  
Physician Decision                 5  
[1] 20 subjects completed the study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Escitalopram Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.

Baseline Measures
    Escitalopram  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.6  ± 8.12  
Gender  
[units: participants]
 
Female     10  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
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1.  Primary:   Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)   [ Time Frame: baseline and 7 weeks ]
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Measure Type Primary
Measure Title Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)
Measure Description 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.
Time Frame baseline and 7 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
3 patients dropped out, 4 patients did not met the criteria, and 3 patients did not show up.

Reporting Groups
  Description
Escitalopram Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Subjects received escitalopram 10-20mg. Escitalopram was started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day.

Measured Values
    Escitalopram  
Number of Participants Analyzed  
[units: participants]
  20  
Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)  
[units: scores on an anxiety scale]
Mean ± Standard Deviation
  21.23  ± 2.57  

No statistical analysis provided for Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)



2.  Primary:   Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory   [ Time Frame: baseline and 7 weeks ]

3.  Secondary:   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 ]

4.  Secondary:   Change From Randomization to End of Treatment for Trail Making Tet (TMT)   [ Time Frame: baseline to 7 weeks ]

5.  Secondary:   Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)   [ Time Frame: baseline and 7 weeks ]

6.  Secondary:   Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)   [ Time Frame: baseline and 7 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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