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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 ]

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 ]

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  
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.
No text entered.

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

Measured Values
    Escitalopram  
Number of 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 ]

Measure Type Secondary
Measure Title Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)
Measure Description

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
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 meet 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.

Measured Values
    Escitalopram  
Number of Participants Analyzed  
[units: participants]
  20  
Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)  
[units: scores on a scale]
Mean ± Standard Deviation
 
Clinical Global Impression (CGI-I)     1  ± 0.0  
Clinical Global Impression (CGI-S)     2  ± 1.0  

No statistical analysis provided for Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)



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

Measure Type Secondary
Measure Title Change From Randomization to End of Treatment for Trail Making Tet (TMT)
Measure Description

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

Time Frame baseline to 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.
No text entered.

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

Measured Values
    Escitalopram  
Number of Participants Analyzed  
[units: participants]
  20  
Change From Randomization to End of Treatment for Trail Making Tet (TMT)  
[units: seconds]
Mean ± Standard Deviation
  29.2  ± 11.23  

No statistical analysis provided for Change From Randomization to End of Treatment for Trail Making Tet (TMT)



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

Measure Type Secondary
Measure Title Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)
Measure Description 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.
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.
No text entered.

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

Measured Values
    Escitalopram  
Number of Participants Analyzed  
[units: participants]
  20  
Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)  
[units: units on a scale]
Mean ± Standard Deviation
  0  ± 0  

No statistical analysis provided for Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)



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

Measure Type Secondary
Measure Title Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)
Measure Description

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.

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.
No text entered.

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

Measured Values
    Escitalopram  
Number of Participants Analyzed  
[units: participants]
  20  
Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)  
[units: units on a scale]
Mean ± Standard Deviation
  0  ± 0  

No statistical analysis provided for Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)




  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
No text entered.


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