BACKGROUND: There is a need for additional studies of the quality of life (QOL) of elderly depressed subjects with medical comorbidity. METHOD: We conducted an 8-week, open trial of bupropion sustained release (SR) in 18 elderly (60-81 years) subjects with DSM-IV major depressive disorder and one or more serious medical illnesses (e.g., congestive heart failure, type 1 diabetes mellitus, irritable bowel syndrome) with a week-12 follow-up interview. The intent-to-treat method with the last observation carried forward was used to analyze depression and QOL measures. Dosing was initiated at 100 mg once daily and increased at weekly intervals to a maximum of 150 mg twice daily as clinically indicated. RESULTS:Bupropion SR treatment was associated with reductions in Clinical Global Impressions-Severity of Illness scale (p <.0001) score and in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score (p <.0001). QOL as measured by the Medical Outcomes Study Short Form-36 (SF-36) also tended to improve with treatment. The SF-36 "mental health" (p <.01) and "social functioning" (p <.0006) domains improved significantly by week 4. "Vitality" (p <.03) improved significantly by week 12. On the HAM-D, statistically significant improvement was noted on "depressed mood" (p <.0001), "feelings of guilt" (p <.01), "work and activities" (p <.001), "hypochondriasis" (p <.02), and "insomnia" (p <.01) at week 8. The mean dose of bupropion SR at endpoint was 222 mg/day, and the drug was relatively well tolerated. Two subjects dropped out owing to adverse events and 2 owing to other reasons. No drug-drug interactions occurred. CONCLUSION: These data suggest that bupropion SR is well tolerated and may improve depression, insomnia, somatic symptoms, work functioning, and certain quality-of-life measures in elderly depressed subjects with medical disorders. A randomized, placebo-controlled study is warranted to confirm these promising findings.
RCT Entities:
BACKGROUND: There is a need for additional studies of the quality of life (QOL) of elderly depressed subjects with medical comorbidity. METHOD: We conducted an 8-week, open trial of bupropion sustained release (SR) in 18 elderly (60-81 years) subjects with DSM-IV major depressive disorder and one or more serious medical illnesses (e.g., congestive heart failure, type 1 diabetes mellitus, irritable bowel syndrome) with a week-12 follow-up interview. The intent-to-treat method with the last observation carried forward was used to analyze depression and QOL measures. Dosing was initiated at 100 mg once daily and increased at weekly intervals to a maximum of 150 mg twice daily as clinically indicated. RESULTS:Bupropion SR treatment was associated with reductions in Clinical Global Impressions-Severity of Illness scale (p <.0001) score and in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score (p <.0001). QOL as measured by the Medical Outcomes Study Short Form-36 (SF-36) also tended to improve with treatment. The SF-36 "mental health" (p <.01) and "social functioning" (p <.0006) domains improved significantly by week 4. "Vitality" (p <.03) improved significantly by week 12. On the HAM-D, statistically significant improvement was noted on "depressed mood" (p <.0001), "feelings of guilt" (p <.01), "work and activities" (p <.001), "hypochondriasis" (p <.02), and "insomnia" (p <.01) at week 8. The mean dose of bupropion SR at endpoint was 222 mg/day, and the drug was relatively well tolerated. Two subjects dropped out owing to adverse events and 2 owing to other reasons. No drug-drug interactions occurred. CONCLUSION: These data suggest that bupropion SR is well tolerated and may improve depression, insomnia, somatic symptoms, work functioning, and certain quality-of-life measures in elderly depressed subjects with medical disorders. A randomized, placebo-controlled study is warranted to confirm these promising findings.
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