HIV Infections Clinical Trial
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.
Verified date | March 2014 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2010 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - age 18 to 65 years, - DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for Generalized Anxiety Disorder - confirmed stable HIV disease and attending a HIV treatment program - stable dose of highly active anti-retroviral therapy for a minimum of 4 weeks - ability to give informed consent Exclusion Criteria: - bipolar disorders, any psychotic disorder - current major depression - substance dependence (except nicotine dependence) in the previous 3 months - currently suicidal or high suicide risk, serious or unstable medical disorders (e.g. uncontrolled hypertension or diabetes) - any hospitalization for HIV-related illness in the previous 3 months - any active CNS (central nervous system) CNS opportunistic infection or CNS malignancies related to HIV - current active treatment for opportunistic infections related to HIV - any psychotropic drug treatment in the previous 2 weeks before screening - history of hypersensitivity to escitalopram and/or citalopram - admission BDI 23 - seizure disorder, traumatic brain injury - pregnant, nursing mother or planning to get pregnant. - Concomitant mediations: At least 2-week washout of antidepressant (4 weeks for fluoxetine) or antipsychotic or anti-anxiety medications. - In the opinion of the investigator the clinical condition precludes participation in the trial. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Forest Laboratories |
United States,
Pence BW, Miller WC, Whetten K, Eron JJ, Gaynes BN. Prevalence of DSM-IV-defined mood, anxiety, and substance use disorders in an HIV clinic in the Southeastern United States. J Acquir Immune Defic Syndr. 2006 Jul;42(3):298-306. — View Citation
Tucker JS, Kanouse DE, Miu A, Koegel P, Sullivan G. HIV risk behaviors and their correlates among HIV-positive adults with serious mental illness. AIDS Behav. 2003 Mar;7(1):29-40. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline and 7 weeks | No |
Primary | 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. 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:[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. |
baseline and 7 weeks | No |
Secondary | 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) = 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 |
baseline and 7 weeks | No |
Secondary | Change From Randomization to End of Treatment for Trail Making Tet (TMT) | 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 |
baseline to 7 weeks | No |
Secondary | 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. | baseline and 7 weeks | No |
Secondary | 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. |
baseline and 7 weeks | No |
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