Back to resultsTreatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
Primary Purpose
Anxiety Disorders, HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring Escitalopram, Anxiety Disorder, HIV and AIDS, treatment experienced
Eligibility Criteria
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.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Escitalopram
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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
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.
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.
Full Information
NCT ID
NCT00887679
First Posted
April 23, 2009
Last Updated
October 23, 2014
Sponsor
Duke University
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00887679
Brief Title
Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
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 Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, HIV Infections
Keywords
Escitalopram, Anxiety Disorder, HIV and AIDS, treatment experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)
Description
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
Title
Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory
Description
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.
Time Frame
baseline and 7 weeks
Secondary Outcome Measure Information:
Title
Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)
Description
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
Time Frame
baseline and 7 weeks
Title
Change From Randomization to End of Treatment for Trail Making Tet (TMT)
Description
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
Title
Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)
Description
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
Title
Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwin A Patkar, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16639343
Citation
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. doi: 10.1097/01.qai.0000219773.82055.aa.
Results Reference
background
PubMed Identifier
14534388
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. doi: 10.1023/a:1022557222690.
Results Reference
background
Learn more about this trial
Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
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