2
Poster Number: NR 09 Prevention of Depression Using Escitalopram in Patients Undergoing Treatment for Head and Neck Cancer William Burke, MD 1 ; Kendra Schmid, PhD 1 ; William Lydiatt, MD 1,2 1 University of Nebraska Medical Center, Omaha, NE 2 Nebraska Methodist Cancer Center, Omaha, NE Introduction: Major depressive disorder develops in up to half of patients undergoing treatment for head and neck cancer resulting in significant morbidity. Preventing depression during the course of cancer treatment may, thus, be of great benefit. To determine whether prophylactic use of the antidepressant escitalopram would decrease the incidence of depression in subjects receiving primary therapy for head and neck cancer. Methods: A randomized, double-blind, placebo-controlled trial of escitalopram versus placebo was conducted in a group of non-depressed subjects diagnosed with head and neck cancer who were about to enter cancer treatment. Subjects were stratified by gender, site, stage (early versus advanced), and by primary modality of treatment (radiation versus surgery). The primary outcome measure was the number of participants who developed moderate or greater depression (scores on the Quick Inventory of Depressive Symptomology-Self Rated > 11). Results: 148 patients were randomized. Significantly fewer subjects receiving escitalopram developed depression (24.6% placebo vs. 10% escitalopram, stratified log-rank test p ¼ 0.04). A Cox proportional hazard regression model compared the two treatment groups after controlling for age, baseline smoking status, and stratification variables. The hazard ratio of 0.37 (95% CI: 0.14, 0.96) demonstrated an advantage of escitalopram (p ¼ 0.04). Patients undergoing radiotherapy as the initial modality were significantly more likely to develop depression than those receiving surgery (radiotherapy, compared to surgery group, HR 3.6 [95% CI: 1.38, 9.40, p ¼ 0.009]). Subjects in the escitalopram group who completed the study and were not depressed rated their overall quality of life as significantly better for 3 consecutive months following cessation of drug. Conclusions: In non-depressed subjects undergoing treatment for head and neck cancer, prophylactic escitalopram reduced the risk of developing depression by more than 50%. In non-depressed subjects who completed the trial, quality of life was also significantly better for 3 consecutive months following cessation of the drug in the escitalopram group. These findings have important implications for management of head and neck patients. Poster Number: NR 10 The Association between Alzheimers Disease Severity as measured by RMBPC and Caregiver-reported Outcomes Michael Durkin, MSc 1 ; Shaloo Gupta, MS 3 ; Deborah Freedman, MBA 3 ; Jonathan Chapnick, BA 3 ; Sonali Shah, PharmD 2 1 Janssen Scientific Affairs, LLC, Titusville, NJ 2 Pfizer, New York, NY 3 Kantar Health, Princeton, NJ Introduction: The objective was to describe the self-reported attributes and outcomes for caregivers of patients with Alzheimers disease (AD) and quantify the association of patient severity with caregiving hours per week reported by caregiver. Methods: From a 2009 survey of 1079 AD caregivers, responses from unpaid primary caregivers of community-dwelling AD patients were selected. Patient severity was calculated from responses to the Revised Memory and Behavioral Problem Checklist (RMBPC) as a continuous (0-4) variable. Caregiver attributes and outcomes were described for three cohorts based on RMBPC; Mild (RMBPC < 1.25), Moderate (1.25 RMBPC < 2.25), and Severe (RMBPC 2.25) and compared using chi-square tests for categorical variables and ANOVA for continuous variables. A generalized linear regression model with a negative binomial distribution was constructed for caregiving hours per weekwith RMBPC, age, gender, marital status, relation to patient, living situation, employment and income as covariates. Results: Of the 849 caregivers meeting study criteria, 18.8% were caring for persons categorized as Mild (n¼160), 52.4% as Moderate (n¼445) and 26.4% as Severe (n¼244). Significant differences (p<0.05) were observed among the severity groups in attributes such as age, relation to AD patient, diagnosed depression and diagnosed anxiety and in caregiver outcomes such as Zarit Caregiver Burden Scale, Desire to Institutionalize Scale, SF-12 Mental and Physical Composite Summary Scores, work days per month missed due to caregiving and caregiving hours per week (Mild¼43.6 hours, Moderate¼ 47.9 hours, Severe¼ 55.1 hours). A positive relationship between RMBPC and caregiving hours was seen in the multivariate analysis, with a 1 point Am J Geriatr Psychiatry 21:3, Supplement 1 S133 2013 AAGP Annual Meeting

The Association between Alzheimer's Disease Severity as measured by RMBPC and Caregiver-reported Outcomes

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2013 AAGP Annual Meeting

Poster Number: NR 09Prevention of Depression Using Escitalopram in Patients Undergoing Treatment for Head and NeckCancerWilliam Burke, MD1; Kendra Schmid, PhD1; William Lydiatt, MD1,2

1University of Nebraska Medical Center, Omaha, NE2Nebraska Methodist Cancer Center, Omaha, NE

Introduction: Major depressive disorder develops in up to half of patients undergoing treatment for head and neck cancerresulting in significant morbidity. Preventing depression during the course of cancer treatment may, thus, be of great benefit.To determine whether prophylactic use of the antidepressant escitalopram would decrease the incidence of depression insubjects receiving primary therapy for head and neck cancer.Methods: A randomized, double-blind, placebo-controlled trial of escitalopram versus placebo was conducted in a group ofnon-depressed subjects diagnosed with head and neck cancer who were about to enter cancer treatment. Subjects were stratifiedby gender, site, stage (early versus advanced), and by primary modality of treatment (radiation versus surgery). The primaryoutcome measure was the number of participants who developed moderate or greater depression (scores on the QuickInventory of Depressive Symptomology-Self Rated > 11).Results: 148 patients were randomized. Significantly fewer subjects receiving escitalopram developed depression (24.6% placebovs. 10% escitalopram, stratified log-rank test p ¼ 0.04). A Cox proportional hazard regression model compared the twotreatment groups after controlling for age, baseline smoking status, and stratification variables. The hazard ratio of 0.37 (95%CI: 0.14, 0.96) demonstrated an advantage of escitalopram (p ¼ 0.04). Patients undergoing radiotherapy as the initial modalitywere significantly more likely to develop depression than those receiving surgery (radiotherapy, compared to surgery group, HR3.6 [95% CI: 1.38, 9.40, p ¼ 0.009]). Subjects in the escitalopram group who completed the study and were not depressed ratedtheir overall quality of life as significantly better for 3 consecutive months following cessation of drug.Conclusions: In non-depressed subjects undergoing treatment for head and neck cancer, prophylactic escitalopram reduced therisk of developing depression by more than 50%. In non-depressed subjects who completed the trial, quality of life was alsosignificantly better for 3 consecutive months following cessation of the drug in the escitalopram group. These findings haveimportant implications for management of head and neck patients.

Poster Number: NR 10The Association between Alzheimer’s Disease Severity as measured by RMBPC and Caregiver-reportedOutcomesMichael Durkin, MSc1; Shaloo Gupta, MS3; Deborah Freedman, MBA3; Jonathan Chapnick, BA3; Sonali Shah, PharmD2

1Janssen Scientific Affairs, LLC, Titusville, NJ2Pfizer, New York, NY3Kantar Health, Princeton, NJ

Introduction: The objective was to describe the self-reported attributes and outcomes for caregivers of patients with Alzheimer’sdisease (AD) and quantify the association of patient severity with caregiving hours per week reported by caregiver.Methods: From a 2009 survey of 1079 AD caregivers, responses from unpaid primary caregivers of community-dwelling ADpatients were selected. Patient severity was calculated from responses to the Revised Memory and Behavioral Problem Checklist(RMBPC) as a continuous (0-4) variable. Caregiver attributes and outcomes were described for three cohorts based on RMBPC;Mild (RMBPC < 1.25), Moderate (1.25 � RMBPC < 2.25), and Severe (RMBPC � 2.25) and compared using chi-square testsfor categorical variables and ANOVA for continuous variables. A generalized linear regression model with a negative binomialdistribution was constructed for ‘caregiving hours per week’ with RMBPC, age, gender, marital status, relation to patient, livingsituation, employment and income as covariates.Results: Of the 849 caregivers meeting study criteria, 18.8% were caring for persons categorized as Mild (n¼160), 52.4% asModerate (n¼445) and 26.4% as Severe (n¼244). Significant differences (p<0.05) were observed among the severity groups inattributes such as age, relation to AD patient, diagnosed depression and diagnosed anxiety and in caregiver outcomes such asZarit Caregiver Burden Scale, Desire to Institutionalize Scale, SF-12 Mental and Physical Composite Summary Scores, workdays per month missed due to caregiving and caregiving hours per week (Mild¼43.6 hours, Moderate¼ 47.9 hours, Severe¼55.1 hours). A positive relationship between RMBPC and caregiving hours was seen in the multivariate analysis, with a 1 point

Am J Geriatr Psychiatry 21:3, Supplement 1 S133

2013 AAGP Annual Meeting

change in RMBPC associated with a 10% change in hours (p¼0.005). Two factors associated with less time caregiving werehousehold income greater than $50,000 (p¼0.013) and living apart from the AD patient (p<0.001).Conclusions: In this survey of unpaid caregivers of AD patients living in the community, differences in caregiver characteristicsand outcomes were quantified among those caring for Mild, Moderate and Severe AD patients. The findings of this studysuggest that higher patient severity is associated with increased burden on caregivers in terms of caregiving time, lost work timeand quality of life.

Caregiver Attributes and Outcomes by Patient Severity

Severity by RMBPC Score

S134

Total (N¼849)

Am J Geriatr Psychiatry 21:3, Suppl

P Value

Mild (N¼160) Moderate (N¼445) Severe (N¼244)

Caregiver Attributes

Age (Mean � SD) 51.09 � 13.43 53.07 � 14.69 51.86 � 13.20 48.39 � 12.63 <.001 Gender (Female) 69.61% 65.00% 70.79% 70.49% 0.370 Relationship to Alzheimer’s Disease Patient 0.007 Spouse/significant other 15.55% 20.63% 16.85% 9.84% Daughter/Son/In-Law 61.96% 61.25% 62.70% 61.07% Grandchild 15.43% 12.50% 13.03% 21.72% Other 7.07% 5.63% 7.42% 7.38% Caregiver Employment 0.838 Full-Time, Part-Time, or Self Employed 55.12% 56.25% 54.16% 56.15% Not Employed 44.88% 43.75% 45.84% 43.85% Diagnosed with Anxiety 28.15% 10.00% 29.44% 37.70% <.001 Diagnosed with Depression 31.21% 11.25% 30.34% 45.90% <.001 Caregiver Outcomes Zarit Caregiver Burden Scale(Mean � SD)

37.45 � 16.90

25.53 � 14.26 37.67 � 15.52 44.86 � 16.56 <.001

Desire To Institutionalize Scale(Mean � SD)

2.50 � 2.03

1.28 � 1.52 2.56 � 2.01 3.18 � 2.02 <.001

SF-12v2: Mental Component Summary(Mean � SD)

42.43 � 11.87

48.41 � 10.67 42.58 � 11.53 38.25 � 11.55 <.001

SF-12v2: Physical Component Summary(Mean � SD)

47.81 � 11.25

49.76 � 9.66 47.95 � 11.22 46.29 � 12.07 0.009

Work Days Missed Due to Caregiving(Mean � SD)

5.95 � 15.13

1.39 � 3.09 5.48 � 12.49 9.75 � 21.76 <.001

Hours per Week ProvidingCare (Mean � SD)

49.12 � 37.36

43.64 � 34.55 47.86 � 37.63 55.06 � 38.00 0.013

Poster Number: NR 11The Association between Patient Dependence and Caregiver Burden in Alzheimer’s DiseaseMichael Durkin, MSc1; Sonali Shah, PharmD2; Shaloo Gupta, MS3; Deborah Freedman, MBA3; Jonathan Chapnick, BA3

1Janssen Scientific Affairs, LLC, Titusville, NJ2Pfizer, New York, NY3Kantar Health, Princeton, NJ

Introduction: The objective was to examine how self-reported burden for caregivers of patients with Alzheimer’s disease (AD)self-reported burden differs by quartile of Dependence Scale (DS) and quantify the association between DS score and ZaritBurden Interview (ZBI) score.Methods: Responses from unpaid primary caregivers of community-dwelling AD patients were analyzed from a 2009 survey of1079 AD caregivers. Patient dependence was evaluated from responses to the 15 item DS. Caregiver outcomes were stratifiedinto four cohorts based on DS quartiles; Q1 (DS¼0-6), Q2 (DS¼7-8), Q3 (DS¼9-10) and Q4 (DS¼11-15) and compared usingchi-square tests for categorical outcomes and ANOVA for continuous variables. Outcomes examined included caregiver burdenas measured by the ZBI and health-related quality of life as measured by the SF-12 and SF-6D. A least squares linear regression

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