Background: Amisulpiride is an atypical antipsychotic used extensively in Schizophrenia and related disorders. The current study explored the safety and tolerability of amisulpride in refractory patients with behavioral and psychological symptoms of dementia (BPSD), especially in agitation and/or aggression.
Method: A 12-weeks observational study was conducted in Northern India. A Total of 39 subjects with dementias receiving antipsychotics divided into 3 groups: 19 patients on amisulpride, 10 patients on other anti-psychotics (olanzapine, quietiapine and risperidone), 10 patients not on any anti-psychotics. A total of 10 healthy volunteers were taken as controls (n=49). The effectiveness of the antipsychotics in BPSD was evaluated by caregiver rated Likert scale. Agitated Behavior Scale (ABS) was used for categorization of nature of BPSD. Safety and tolerability was assessed using Naranjo Adverse Drug Reaction Probability Scale.
Results: A total of 39 subjects [M: F=29: 10] with mean age 70±8.1 years, and with mean duration of illness 4.2±2.5 years were recruited. The Mini Mental State Examination (MMSE) was 9.13±8.5. A comparison of ABS scores using Analysis of Variance (ANOVA) showed all groups were statistically different (p<0.0001). The Agitated Behavior Scale Scores (ABS scores) were significantly different when groups on antipsychotics were compared with the BPSD patients not on antipsychotic (p<0.001). ABS scores comparisions using paired t-test showed that the amisulpride group was significantly different before and after the amisulpride treatment (p<0.0001). ABS scores and MMSE had a statistically significant correlation (Pearson correlation coefficient=0.41).
Conclusions: Amisulpride 100mg/day was safe and well tolerated in patients with refractory BPSD especially in patients with aggression and/or agitation. The tolerability was equivalent to other antipsychotics used routinely in BPSD variety. The self-rated caregiver rating of antipsychotic effectiveness using Likert scale showed the amisulpride had a comparable effectiveness with that of other antipsychotics used routinely in dementias with BPSD.
Keywords: Amisulpride; Effectiveness; Antipsychotics; Safety; Tolerability; BPSD
Published on: Jan 3, 2017 Pages: 1-6
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