Anxiety Disorders, HIV Infections
Conditions
Keywords
Escitalopram, Anxiety Disorder, HIV and AIDS, treatment experienced
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.
Interventions
DRUGEscitalopram
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.
Sponsors
Forest Laboratories
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A) | 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 | baseline and 7 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I) | baseline and 7 weeks | 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 |
| Change From Randomization to End of Treatment for Trail Making Tet (TMT) | 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) | 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) | baseline and 7 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Anxiety disorders in HIV-infected patients from the general population
Participants by arm
| Arm | Count |
|---|---|
| Escitalopram Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Escitalopram |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 43.6 years STANDARD_DEVIATION 8.12 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: baseline and 7 weeks
Population: 3 patients dropped out, 4 patients did not met the criteria, and 3 patients did not show up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A) | 21.23 scores on an anxiety scale | Standard Deviation 2.57 |
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. 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory | 27.8 units on a scale | Standard Deviation 7.89 |
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
Time frame: baseline to 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Change From Randomization to End of Treatment for Trail Making Tet (TMT) | 29.2 seconds | Standard Deviation 11.23 |
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) 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
Population: 3 patients dropped out, 4 patients did not meet criteria, and 3 patients did not show up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Escitalopram | Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I) | Clinical Global Impression (CGI-I) | 1 scores on a scale | Standard Deviation 0 |
| Escitalopram | Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I) | Clinical Global Impression (CGI-S) | 2 scores on a scale | Standard Deviation 1 |
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.
Time frame: baseline and 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE) | 0 units on a scale | Standard Deviation 0 |
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.
Time frame: baseline and 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS) | 0 units on a scale | Standard Deviation 0 |