Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
|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.
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|