Trial Outcomes & Findings for Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS (NCT NCT00887679)

Anxiety disorders in HIV-infected patients from the general population

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

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.

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.

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

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

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.

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.