The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and effective in the treatment of HIV-infected patients with generalized anxiety disorder.
Anxiety disorders are twice as prevalent among HIV-infected patients as they are in the general population. Approximately 25%-40% of HIV-infected patients have anxiety disorders; Generalized Anxiety Disorder, Panic disorder and post-traumatic Stress Disorder being the most frequent. Non-adherence to anti-retroviral medications is commonly seen in patients with HIV with GAD.The role of specific selective serotonin reuptake (SSRIs) in the treatment of HIV-patients with GAD is unclear. Escitalopram has been used in the treatment of GAD in the general population. It has been shown to be safe in HIV-patients with a tolerable side-effect profile. However, whether it can improve GAD in HIV-infected patients has not yet been investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Duke University Medical Center
Durham, North Carolina, United States
Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)
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
Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory
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
Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)
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
Change From Randomization to End of Treatment for Trail Making Tet (TMT)
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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
Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)
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
Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)
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