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Identification and treatment of depression in residents of long term care facilities

University of British Columbia

OBJECTIVES: 1. To develop screening protocol for identifying long term care (LTC) residents with major depression suitable for participation in a clinical drug trial; 2. To conduct a pilot clinical trial of fluoxetine 5 mg and 20 mg daily and estimate the treatment success rate in elderly depressed LTC patients. DESIGN: All capable LTC residents were initially screened for depression. Subsequently, a pilot study for the clinical drug trial was conducted as a randomized, double-blind, multicentre, parallel, fixed-dose, dose-response trial with a one week placebo period, a 14 week treatment period, a 2 week drug-free period, and then an optional open-label continuation period. SETTING: Three medium-sized intermediate-care LTC facilities with medical services provided by primary care physicians, and a total study sample of 315 residents over 65 years of age. PATIENTS: The LTC study sample was 72 percent female and had a mean age of 84 (± 8) years. Following administration of the Geriatric Depression Scale (GDS), Mini-Mental State Exam (MMSE), and Hamilton Rating Scale for Depression (HAM-D), 206 patients (65 %) were able to complete the screen, 155 (49 %) had a MMSE score > 19, 59 (19 %) had a G D S > 11, 21 (7 %) met the criteria for the clinical drug trial, and 17 (5 %) signed the informed consent to enter the trial. Of the patients who entered the trial, 15 were randomized into treatment groups, 8 completed the trial, and 6 met the criteria for treatment success. INTERVENTION: During the pilot study, patients received oral fluoxetine 5 mg or 20 mg daily. Maintenance therapy for concomitant medical conditions was continued. Benzodiazepines for hypnotic/sedative use were permitted and usage recorded. MEASUREMENTS AND MAIN RESULTS: For those 155 patients with a MMSE >19, the distribution of GDS-30 scores suggested that 79 (51%) of patients were not depressed, and 76 (49 %) had a GDS score > 11 suggestive of depression. The correlation between the GDS-3 0 and HAM-D was 0.88 in patients with a MMSE > 19. Using the HAM-D criterion for major depression as the clinical standard, a GDS-30 cutoff score of 13 had a sensitivity of 100 %, and a specificity of 81 %. The mean time to administer the GDS-30 was 8.4 minutes (± 5.6); the HAM-D required 21.8 minutes ( ± 9.8). When screened, 44 patients (15% of the total LTC sample) were receiving antidepressants, and in the 30 of these patients with a MMSE > 19, 10 (33 % o f those on antidepressants) had a HAM-D > 18. When the results of all 8 patients who completed the pilot study were combined, the mean HAM-D score declined-from 20.6 (± 1.9) at the end of baseline to 8.1 (± 2.3) at the end of the study at Week 14. Six of the 8 patients who completed the trial met the criteria for treatment success. It was estimated that a total o f 126 patients would be required in a full clinical trial to detect a difference of 30 percent in treatment success with a power of 90 % and a level of significance of a = 0.05. Exploratory findings for the pooled patients who completed the trial found the following significant changes (p < 0.05) between the end of baseline and the end of study: GDS 17.8 ± 2.3 to 12.6 ± 4.0; CGI (severity) 4.4 ± 0.5 to 2.3 ± 0.7; and CGI (improvement) 4.1 ± 0.6 to 1.9 ±0.6. A substantial proportion of patients in both treatment groups had somatic symptoms present at baseline. Twenty-one treatment-emergent side effects were experienced by the 7 patients on 5 mg fluoxetine daily, while 24 treatment-emergent side effects were experienced by the 8 patients on 20 mg daily. Few treatment-emergent side effects occurred after 6 weeks of drug therapy. For the 8 patients who completed the trial, health status measures of 6 out of 8 health domains improved over the 14 week duration of the trial, with the magnitude of change in the range o f 20 to 75 %. CONCLUSIONS: Screening LTC residents with the GDS, MMSE, and then the HAM-D was an efficient and cost-effective method to identify potential candidates for a clinical drug trial in major depression. When data were combined for the groups treated with 5 mg and 20 mg fluoxetine daily for 14 weeks, 40 % of these elderly LTC patients experienced treatment success an d few late treatment-emergent side effects were observed.

Thesis/Dissertation

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2009-01-10

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http://hdl.handle.net/2429/3538

Pharmaceutical Sciences

University of British Columbia

UBCV

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