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A Pilot Randomized Trial of Carbamazepine for Behavioral Symptoms in Treatment-Resistant Outpatients with Alzheimer Disease

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The authors performed a 6-week, randomized, double-blind, placebo-controlled, parallel-group trial of carbamazepine (400 mg/day) with 21 agitated subjects (16 completers) who had been treated unsuccessfully with antipsychotics. There was greater improvement for the carbamazepine group on the Clinical Global Impression of Change (P = 0.055) and the Brief Psychiatric Rating Scale (BPRS) Hostility item (P = 0.009), with a trend toward worsening on the BPRS Hallucination item (P = 0.067). Overall, carbamazepine showed modest clinical benefit in these subjects, who had not responded to antipsychotics, and particular benefit for hostility. The effect on global ratings was similar to those found in an earlier report in nursing home residents.

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Subjects and Settings

Subjects met the following inclusion criteria: NINCDS-ADRDA criteria for probable or possible AD;14 ≥55 years of age; living with a caregiver; Hachinski ischemic score ≤4; Mini-Mental State Exam (MMSE) score ≤23;15 poor response to previous neuroleptic treatment, based on caregiver report and medical records review (all subjects had been seen for an extensive length of time before participation in this study, having originally enrolled in earlier clinical trials, then followed by the clinic

RESULTS

Twenty-one subjects were entered; 9 were randomly assigned to carbamazepine, 12 to placebo. Fourteen were women; the mean age was 74.7±6.23 years (range: 63–86); seven had less than a high school education, five had completed high school, 8 had some college, and one completed college. Fifteen subjects were white, three were African-American, and three were Hispanic. No significant differences were found between treatment groups at baseline.

Sixteen subjects completed 6 weeks of the trial, with

DISCUSSION

These severely cognitively impaired individuals with AD were selected on the basis of predominant symptoms of hostility, uncooperativeness, and tension and had been treated previously with neuroleptics. Carbamazepine treatment showed a beneficial effect on clinicians' global ratings, largely because more placebo-treated subjects worsened, compared with carbamazepine-treated subjects, and because of an improvement in Hostility ratings. Three of the four dropouts in the placebo group did so

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Portions of these data were presented at the meeting of the American Association of Geriatric Psychiatry, Miami, FL, March 14, 2000, and at the Seventh International Conference on Alzheimer's Disease and Related Disorders, Washington, DC, July 11, 2000.

This research was supported by grants from the National Institute of Mental Health (MH01368 [to Dr. Olin], MH48759 [Dr. Schneider]), the Alzheimer's Association (898014 [Dr. Schneider]), and the Southern California Alzheimer's Disease Research Center (AG05142).

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