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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

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
Enrollment 30

Recruitment Details Anxiety disorders in HIV-infected patients from the general population
Pre-assignment Details  
Arm/Group Title Escitalopram
Hide Arm/Group Description Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
Period Title: Overall Study
Started 30
Completed 20 [1]
Not Completed 10
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             4
Physician Decision             5
[1]
20 subjects completed the study.
Arm/Group Title Escitalopram
Hide Arm/Group Description Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
43.6  (8.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
10
  33.3%
Male
20
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3 patients dropped out, 4 patients did not met the criteria, and 3 patients did not show up.
Arm/Group Title Escitalopram
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: scores on an anxiety scale
21.23  (2.57)
2.Primary Outcome
Title Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram
Hide Arm/Group Description:
Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
27.8  (7.89)
3.Secondary Outcome
Title Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3 patients dropped out, 4 patients did not meet criteria, and 3 patients did not show up.
Arm/Group Title Escitalopram
Hide Arm/Group Description:
Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Clinical Global Impression (CGI-I) 1  (0.0)
Clinical Global Impression (CGI-S) 2  (1.0)
4.Secondary Outcome
Title Change From Randomization to End of Treatment for Trail Making Tet (TMT)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram
Hide Arm/Group Description:
Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: seconds
29.2  (11.23)
5.Secondary Outcome
Title Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram
Hide Arm/Group Description:
Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
0  (0)
6.Secondary Outcome
Title Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram
Hide Arm/Group Description:
Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
0  (0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram
Hide Arm/Group Description Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
All-Cause Mortality
Escitalopram
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Escitalopram
Affected / at Risk (%)
Total   21/30 (70.00%) 
Gastrointestinal disorders   
nause  7/30 (23.33%) 
diarrhea  3/30 (10.00%) 
dry mouth  4/30 (13.33%) 
constipation *  2/30 (6.67%) 
Nervous system disorders   
dizziness  4/30 (13.33%) 
headache *  1/30 (3.33%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ashwin A Patkar Associate Professor
Organization: Duke University Medical Center
Phone: 919-668-3626
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00887679     History of Changes
Other Study ID Numbers: Pro00011288
LXP-MD-0148
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: November 19, 2012
Results First Posted: March 10, 2014
Last Update Posted: October 31, 2014