Table 2.
NPI Domains | Symptom Severity |
# of relapses by week 32 (n/total) |
p-value2 | ||
---|---|---|---|---|---|
Risperidone Continued |
Risperidone Discontinued |
||||
At Baseline (Week 0) |
Hallucination | Absent | 13 / 44 | 11 / 23 | 0.35 |
Mild | 6 / 19 | 3 / 6 | |||
Severe | 4 / 7 | 10 / 11 | |||
Delusions | Absent | 5 / 11 | 0 / 4 | 0.44 | |
Mild | 6 / 28 | 7 / 9 | |||
Severe | 12 / 31 | 17 / 27 | |||
Agitation/Aggression | Absent | 2 / 3 | 4 / 5 | 0.15 | |
Mild | 11 / 33 | 6 / 15 | |||
Severe | 10 / 34 | 14 / 20 | |||
Depression/Dysphoria | Absent | 13 / 41 | 11 / 21 | 0.14 | |
Mild | 8 / 25 | 11 / 16 | |||
Severe | 2 / 4 | 2 / 3 | |||
Anxiety | Absent | 7 / 25 | 20 / 29 | 0.17 | |
Mild | 10 / 32 | 3 / 8 | |||
Severe | 6 / 13 | 1 / 3 | |||
Elation/Euphoria1 | Absent | 22 / 64 | 23 / 38 | 0.88 | |
Present | 1 / 6 | 1 / 2 | |||
Apathy/Indifference | Absent | 15 / 44 | 14 / 22 | 0.07 | |
Mild | 1 / 13 | 8 / 13 | |||
Severe | 7 / 13 | 2 / 5 | |||
Disinhibition | Absent | 14 / 38 | 10 / 19 | 0.38 | |
Mild | 6 / 23 | 11 / 15 | |||
Severe | 3 / 9 | 3 / 6 | |||
Irritability/Lability* | Absent | 6 / 17 | 4 / 11 | 0.03 | |
Mild | 13 / 32 | 7 / 15 | |||
Severe | 4 / 21 | 13 / 14 | |||
Aberrant Motor | Absent | 12 / 39 | 15 / 26 | 0.65 | |
Mild | 6 / 15 | 4 / 6 | |||
Severe | 5 / 16 | 5 / 8 | |||
Sleep | Absent | 15 / 49 | 20 / 32 | 0.27 | |
Mild | 3 / 14 | 3 / 6 | |||
Severe | 5 / 7 | 1 / 2 | |||
Appetite | Absent | 12 / 39 | 14 / 24 | 0.33 | |
Mild | 8 / 19 | 4 / 9 | |||
Severe | 3 / 12 | 6 / 7 | |||
At Randomization (Week 16) |
Hallucination | Absent | 19 / 60 | 21 / 35 | 0.31 |
Mild | 4 / 10 | 3 / 5 | |||
Delusions1,* | Absent | 15 / 50 | 19 / 24 | 0.02 | |
Present | 8 / 20 | 5 / 16 | |||
Agitation/Aggression | Absent | 12 / 36 | 15 / 24 | 0.82 | |
Mild | 11 / 32 | 8 / 15 | |||
Severe | 0 / 2 | 1 / 1 | |||
Depression/Dysphoria | Absent | 17 / 57 | 19 / 33 | 0.97 | |
Mild | 4 / 11 | 5 / 7 | |||
Severe | 2 / 2 | 0 / 0 | |||
Anxiety | Absent | 12 / 47 | 19 / 30 | 0.10 | |
Mild | 10 / 22 | 5 / 10 | |||
Severe | 1 / 1 | 0 / 0 | |||
Elation/Euphoria | Absent | 23 / 69 | 24 / 40 | NA | |
Severe | 0 / 1 | 0 / 0 | |||
Apathy/Indifference | Absent | 11 / 39 | 18 / 29 | 0.36 | |
Mild | 9 / 20 | 5 / 9 | |||
Severe | 3 / 11 | 1 / 2 | |||
Disinhibition1 | Absent | 18 / 62 | 19 / 33 | 0.29 | |
Present | 5 / 8 | 5 / 7 | |||
Irritability/Lability | Absent | 17 / 44 | 17 / 26 | 0.89 | |
Mild | 6 / 26 | 7 / 14 | |||
Aberrant Motor | Absent | 14 / 46 | 20 / 31 | 0.68 | |
Mild | 6 / 18 | 3 / 6 | |||
Severe | 3 / 6 | 1 / 3 | |||
Sleep | Absent | 18 / 59 | 20 / 33 | 0.56 | |
Mild | 3 / 8 | 2 / 4 | |||
Severe | 2 / 3 | 2 / 3 | |||
Appetite | Absent | 21 / 56 | 22 / 34 | 0.40 | |
Mild | 1 / 11 | 2 / 6 | |||
Severe | 1 / 3 | 0 / 0 |
p<0.05
Due to the small number of patients with severe symptoms, severe and mild symptom groups were merged and are classified as Present.
P-values for the interaction between risperidone discontinuation status and symptom severity in the stratified Cox proportional hazard regression models. Stratification factors were nursing home status and presence of psychosis.