Table 1.
Study Subject Demographic and Baseline Data for ITT Population
| Variable | JNJ-67953964 N=45 | Placebo N=44 | Total N=89 |
|---|---|---|---|
| Mean Age in Years (SD) | 40.7 (13.3) | 38.2 (13.0) | 39.5 (13.2) |
| Gender - %Female | 64.4 | 61.4 | 62.9 |
| Race | |||
| %Caucasian | 70.5 | 65.1 | 67.8 |
| %African American | 22.7 | 18.6 | 20.7 |
| %Asian | 2.3 | 4.7 | 3.4 |
| %American Indian/Alaskan Native | 0.0 | 2.3 | 1.1 |
| %More Than One Race | 4.5 | 9.3 | 6.9 |
| Ethnicity - %Hispanic Origin | 11.6 | 11.6 | 11.6 |
| Mean BMI (SD) | 29.4 (6.4) | 28.0 (5.9) | 28.7 (6.2) |
| Mean Weight (lbs) (SD) | 180.9 (43.7) | 180.3 (40.6) | 180.6 (41.9) |
| Mean Baseline fMRI Ventral Striatal Activation in MID Task in Anticipation of Gain_Contrasted with No-incentive Trials (SD)** | 0.63 (0.9) (N=44) | 0.64 (0.8) (N=44) | 0.63 (0.8) (N=88) |
| Mean Maximum Baseline fMRI Ventral Striatal Activation in MID Task (SD) in Anticipation of Gain Contrasted with No-Incentive Trials (SD) | 2.66 (1.2) (N=44) | 2.73 (1.2) (N=44) | 2.70 (1.2) (N=88) |
| Mean Baseline fMRI Ventral Striatal Activation in MID Task in Anticipation of Loss Contrasted with No-incentive Trials (SD) | 0.29 (0.8) (N=44) | 0.36 (0.7) (N=44) | 0.33 (0.7) (N=88) |
| Mean Maximum Baseline fMRI Ventral Striatal Activation in MID Task (SD) in Anticipation of Loss Contrasted with No-incentive Trials (SD) | 2.15 (1.2) (N=44) | 2.23 (0.9) (N=44) | 2.19 (1.0) (N=88) |
| Mean Baseline PRT Change in Response Bias from Block 1 to Block 2 (SD)* | 0.02 (0.2) (N=42) | 0.05 (0.2) (N=44) | 0.04 (0.2) (N=86) |
| Mean Baseline SHAPS (SD)* | 36.4 (8.5) (N=44) | 33.4 (5.9) (N=44) | 34.9 (7.4) (N=88) |
| Mean Baseline PRT Response Bias (averaged across blocks) (SD) | 0.108 (0.027) (N=24) | 0.113 (0.025) (N=31) | 0.111(0.026) (N=55) |
| Mean Baseline EEfRT (SD) | 0.35 (0.2) (N=42) | 0.38 (0.2) (N=41) | 0.36 (0.2) (N=83) |
| Mean Baseline TEPS Anticipatory Subscore (SD) | 29.3 (5.7) (N=44) | 29.5 (5.6) (N=44) | 29.4 (5.7) (N=88) |
| Means Baseline TEPS Consummatory Subscore (SD) | 26.3 (4.4) (N=44) | 26.1 (4.4) (N=44) | 26.2 (4.4) (N=88) |
| Mean Baseline VAS Anhedonia (SD) | 2.93 (2.1) (N=44) | 3.59 (2.2) (N=44) | 3.26 (2.2) (N=88) |
| Mean Baseline Resting State EEG Delta Current Density in Rostral Anterior Cingulate (SD) | 73.0 (97.1) (N=43) | 75.2 (51.6) (N=38) | 74.0 (78.6) (N=81) |
| Mean Baseline HAM-D (SD) | 16.3 (5.2) | 14.8 (5.9) | 15.6 (5.6) |
| Mean Baseline HAM-A (SD) | 16.0 (5.8) | 15.1 (6.6) | 15.5 (6.2) |
| Mean Baseline CGI-S (SD) | 3.9 (0.6) | 4.0 (0.5) | 3.9 (0.5) |
| Mean Baseline CPFQ (SD) | 27.2 (6.4) (N=44) | 25.4 (5.7) (N=44) | 26.3 (6.1) (N=44) |
Note: No variables different between groups at p<0.05 level;
Number of subjects is 45 in the JNJ-67953964 and 44 in the Placebo group unless otherwise stated in the table;
When the N’s are less than 45/44 it was due to missing baseline data for that variable;
**
A priori specified primary outcome measure;
*
A priori specified secondary outcome measure.