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: March 7, 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


  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.
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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 ]

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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