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A randomized, placebo-controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer's disease in outpatients treated with donepezil.
Int J Geriatr Psychiatry 2004; 19(1):9-18IJ

Abstract

OBJECTIVE

To examine the safety and efficacy of sertraline augmentation therapy in the treatment of behavioral manifestations of Alzheimer's disease (AD) in outpatients treated with donepezil.

METHODS AND MATERIALS

Patients with probable or possible AD, and a Neuropsychiatric Inventory (NPI) total score >5 (with a severity score > or =2 in at least one domain), were treated with donepezil (5-10 mg) for 8 weeks, then randomly assigned to 12 weeks of double-blind augmentation therapy with either sertraline (50-200 mg) or placebo. Primary efficacy measures were the 12-item Neuropsychiatric Inventory (NPI) and the Clinical Global Impression Improvement (CGI-I) and Severity (CGI-S) scales.

RESULTS

24 patients were treated with donepezil+sertraline and 120 patients with donepezil+placebo. There were no statistically significant differences at endpoint on any of the three primary efficacy measures. However, a linear mixed model analysis found modest but statistically significantly greater improvements in the CGI-I score on donepezil+sertraline. Moreover, in a sub-group of patients with moderate-to-severe behavioral and psychological symptoms of dementia, 60% of patients on sertraline vs 40% on placebo (p = 0.006) achieved a response (defined as > or = 50% reduction in a four-item NPI-behavioral subscale). One adverse event (diarrhea) was significantly (p < 0.05) more common in the donepezil+sertraline group compared to the donepezil+placebo group.

CONCLUSION

Sertraline augmentation was well-tolerated in this sample of AD outpatients. In addition, post hoc analyses demonstrated a modest but statistically significant advantage of sertraline over placebo augmentation in mixed model analyses and a clinically and statistically significant advantage in a subgroup of patients with moderate-to-severe behavioral and psychological symptoms of dementia.

Authors+Show Affiliations

Department of Psychiatry, University of Chicago Medical School, and the Leonard Schanfield Research Institute at Council for Jewish Elderly, Chicago, IL 60091, USA. sfinkel104@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14716694

Citation

Finkel, Sanford I., et al. "A Randomized, Placebo-controlled Study of the Efficacy and Safety of Sertraline in the Treatment of the Behavioral Manifestations of Alzheimer's Disease in Outpatients Treated With Donepezil." International Journal of Geriatric Psychiatry, vol. 19, no. 1, 2004, pp. 9-18.
Finkel SI, Mintzer JE, Dysken M, et al. A randomized, placebo-controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer's disease in outpatients treated with donepezil. Int J Geriatr Psychiatry. 2004;19(1):9-18.
Finkel, S. I., Mintzer, J. E., Dysken, M., Krishnan, K. R., Burt, T., & McRae, T. (2004). A randomized, placebo-controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer's disease in outpatients treated with donepezil. International Journal of Geriatric Psychiatry, 19(1), pp. 9-18.
Finkel SI, et al. A Randomized, Placebo-controlled Study of the Efficacy and Safety of Sertraline in the Treatment of the Behavioral Manifestations of Alzheimer's Disease in Outpatients Treated With Donepezil. Int J Geriatr Psychiatry. 2004;19(1):9-18. PubMed PMID: 14716694.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, placebo-controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer's disease in outpatients treated with donepezil. AU - Finkel,Sanford I, AU - Mintzer,Jacobo E, AU - Dysken,Maurice, AU - Krishnan,K R R, AU - Burt,Tal, AU - McRae,Thomas, PY - 2004/1/13/pubmed PY - 2004/4/2/medline PY - 2004/1/13/entrez SP - 9 EP - 18 JF - International journal of geriatric psychiatry JO - Int J Geriatr Psychiatry VL - 19 IS - 1 N2 - OBJECTIVE: To examine the safety and efficacy of sertraline augmentation therapy in the treatment of behavioral manifestations of Alzheimer's disease (AD) in outpatients treated with donepezil. METHODS AND MATERIALS: Patients with probable or possible AD, and a Neuropsychiatric Inventory (NPI) total score >5 (with a severity score > or =2 in at least one domain), were treated with donepezil (5-10 mg) for 8 weeks, then randomly assigned to 12 weeks of double-blind augmentation therapy with either sertraline (50-200 mg) or placebo. Primary efficacy measures were the 12-item Neuropsychiatric Inventory (NPI) and the Clinical Global Impression Improvement (CGI-I) and Severity (CGI-S) scales. RESULTS: 24 patients were treated with donepezil+sertraline and 120 patients with donepezil+placebo. There were no statistically significant differences at endpoint on any of the three primary efficacy measures. However, a linear mixed model analysis found modest but statistically significantly greater improvements in the CGI-I score on donepezil+sertraline. Moreover, in a sub-group of patients with moderate-to-severe behavioral and psychological symptoms of dementia, 60% of patients on sertraline vs 40% on placebo (p = 0.006) achieved a response (defined as > or = 50% reduction in a four-item NPI-behavioral subscale). One adverse event (diarrhea) was significantly (p < 0.05) more common in the donepezil+sertraline group compared to the donepezil+placebo group. CONCLUSION: Sertraline augmentation was well-tolerated in this sample of AD outpatients. In addition, post hoc analyses demonstrated a modest but statistically significant advantage of sertraline over placebo augmentation in mixed model analyses and a clinically and statistically significant advantage in a subgroup of patients with moderate-to-severe behavioral and psychological symptoms of dementia. SN - 0885-6230 UR - https://www.unboundmedicine.com/medline/citation/14716694/A_randomized_placebo_controlled_study_of_the_efficacy_and_safety_of_sertraline_in_the_treatment_of_the_behavioral_manifestations_of_Alzheimer's_disease_in_outpatients_treated_with_donepezil_ L2 - https://doi.org/10.1002/gps.998 DB - PRIME DP - Unbound Medicine ER -