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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:
ClinicalTrials.gov Identifier:
NCT00887679
First Posted: April 24, 2009
Last Update Posted: October 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University
Results First Submitted: November 19, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ]
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Measure Type Primary
Measure Title Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory
Measure Description

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.

Time Frame baseline and 7 weeks  

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.

Measured Values
   Escitalopram 
Participants Analyzed 
[Units: Participants]
 20 
Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory 
[Units: Units on a scale]
Mean (Standard Deviation)
 27.8  (7.89) 

No statistical analysis provided for Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory



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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  More Information