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
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders HIV Infections||Drug: Escitalopram||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder, Adherence to Antiretroviral Therapy,Cognition, and Immune Status Among Patients With HIV and AIDS: A 6-week Open-label, Prospective, Pilot Trial.|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2010|
Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Open label, rater-blinded, prospective, 6-week trial of escitalopram.Subjects received escitalopram 10-20mg. Escitalopram was started at 10mg per day and augmented weekly in 10mg per day increments, the maximum dose being 20mg per day.
10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.
- Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: baseline and 7 weeks ]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.
- Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory [ Time Frame: baseline and 7 weeks ]
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.
- I feel sad.
- I am sad all the time and I can't snap out of it.
- 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: 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.
- 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 ]
Scale for scoring:
Clinical Global Impression(CGI-S)
- = Normal, no symptoms
- = Borderline ill
- = Mildly ill
- = Moderately ill
- = Markedly ill
- = Severely ill
- = Most extremely ill
Clinical Global Impression(CGI-I)-improvement since treatment
- very much improved
- much improved
- minimally improved
- no change from baseline
- minimally worse
- much worse
- very much worse
- Change From Randomization to End of Treatment for Trail Making Tet (TMT) [ Time Frame: baseline to 7 weeks ]
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
- Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE) [ Time Frame: baseline and 7 weeks ]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.
- Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS) [ Time Frame: baseline and 7 weeks ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887679
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Ashwin A Patkar, MD||Duke University|