Table 1.
Baseline Demographic and Clinical Characteristics of Patients in the Modified Intent to Treat Population
| Characteristic | Paliperidone palmitate (n=145) |
Haloperidol decanoate (n=145) |
|---|---|---|
| Demographic characteristics | ||
| Age, mean (SD), y | 43 (12.6) | 45 (12.3) |
| Sex, No. (%) | ||
| Male | 106 (73.1) | 110 (75.9) |
| Female | 39 (26.9) | 35 (24.1) |
| Race, No. (%) | ||
| White | 56 (38.6) | 54 (37.2) |
| Black | 83 (57.2) | 83 (57.2) |
| Othera | 6 (4.1) | 8 (5.5) |
| Spanish, Hispanic, or Latino ethnicity, No. (%) | 6 (4.1) | 8 (5.5) |
| Baseline clinical characteristics | ||
| In hospital, No. (%) | 24 (16.6) | 28 (19.3) |
| Weight, mean (SD), kg | 90 (21.7) | 90 (22.5) |
| BMI, mean (SD) | 30 (7.4) | 30 (7.3) |
| HbA1c (%) (SD) | 5.9 (1.3) | 5.6 (0.6) |
| Blood glucose (mg/dL) (SD) | 104.0 (31.5) | 94.6 (17.6) |
| Total Cholesterol (mg/dL) (SD) | 179.7 (38.5) | 181.5 (41.9) |
| LDL-cholesterol (mg/dL) (SD) | 104.6 (35.1) | 108.1 (33.0) |
| Triglycerides (mg/dL) (SD) | 123.2 (85.4) | 119.9 (80.5) |
| Prolactin (µg/L) men (SD) | 17.4 (20.8) | 17.8 (13.5) |
| Prolactin (µg/L) women (SD) | 35.9 (35.2) | 32.2 (38.5) |
| PANSS total score, mean (SD)b | 73 (15.3) | 70 (15.7) |
| CGI severity score, mean (SD)c | 4.0 (0.8) | 3.8 (0.9) |
| AIMS global severity score, median (range)d | 0.0 (0–2) | 0.0 (0–2) |
| SAS mean score, median (range)e | 0.0 (0–1.5) | 1.0 (0–1.5) |
| BAS global score, median (range)f | 0.0 (0–3) | 0.0 (0–3) |
| Psychiatric history, mean (SD) | ||
| Age at 1st treatment for any behavioral or emotional problem, years | 23 (9.3) | 24 (10.9) |
| Age at 1st antipsychotic medication, years | 26 (9.0) | 27 (10.1) |
| SCID diagnosis, No. (%) | ||
| Schizophrenia – lifetime | 103 (71.0) | 107 (73.8) |
| Schizoaffective disorder – lifetime | 56 (38.6) | 53 (36.6) |
| Major depression – past 5 years | 36 (24.8) | 40 (27.6) |
| Alcohol dependence – past 5 years | 27 (18.6) | 27 (18.6) |
| Alcohol abuse – past 5 years | 42 (29.0) | 43 (29.7) |
| Drug dependence – past 5 years | 33 (22.8) | 36 (24.8) |
| Drug abuse – past 5 years | 50 (34.5) | 45 (31.0) |
| Antisocial personality disorder – past 5 years | 17 (11.8) | 16 (11.0) |
Abbreviations: AIMS, Abnormal Involuntary Movement Scale; BAS, Barnes akathisia scale; BMI, body mass index; CGI, Clinical Global Impressions Scale; PANSS, Positive and Negative Syndrome Scale; SAS, Simpson-Angus Scale; SCID, Structured Clinical Interview for DSM-IV; SD, standard deviation.
Race was self-reported. “Other” includes American Indian or Alaska Native, Asian, or Native Hawaiian or other Pacific Islander and two or more races.
PANSS range is 30–210, with higher scores reflecting greater severity of psychopathology
CGI range is 1–7 with higher scores reflecting greater severity of illness
AIMS global score range is 0–4 higher scores reflecting greater severity of abnormal movements
SAS mean score range is 0–4 with higher scores reflecting greater severity of Parkinson’s symptoms
BAS global score range is 0–3 with higher scores reflecting greater severity of akathisia