Table 3.
Secondary Outcome Measure | |||||||||
---|---|---|---|---|---|---|---|---|---|
Month | Baseline | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 |
SOFAS | |||||||||
Year 1 completers | |||||||||
n | 108 | 106 | 101 | 104 | 105 | 95 | 77 | 57 | 33 |
Mean ± s.d | 50.4 ± 11.62 | 57.4 ± 11.41*** | 57.9 ± 11.37*** | 59.4 ± 12.31*** | 61.0 ± 12.86*** | 61.0 ± 13.41*** | 62.1 ± 12.73*** | 62.4 ± 12.93*** | 65.1 ± 11.57*** |
Year 2 completers | |||||||||
n | 33 | 33 | 31 | 33 | 33 | 33 | 33 | 33 | 33 |
Mean ± s.d | 52.6 ± 11.38 | 58.0 ± 10.37** | 60.8 ± 11.73*** | 60.7 ± 10.83*** | 64.1 ± 12.63*** | 63.7 ± 11.50*** | 63.9 ± 9.45*** | 64.1 ± 11.66*** | 65.1 ± 11.57*** |
CGI-S | |||||||||
Year 1 completers | |||||||||
n | 108 | 105 | 100 | 103 | 106 | 93 | 74 | 54 | 32 |
Mean ± s.d | 4.1 ± 0.78 | 3.5 ± 0.86*** | 3.3 ± 0.84*** | 3.2 ± 0.93*** | 3.1 ± 0.96*** | 3.1 ± 0.93*** | 3.0 ± 0.94*** | 3.0 ± 0.98*** | 2.9 ± 0.76*** |
Year 2 completers | |||||||||
n | 33 | 33 | 31 | 33 | 33 | 33 | 31 | 33 | 32 |
Mean ± s.d | 3.8 ± 0.68 | 3.4 ± 0.66** | 3.2 ± 0.73*** | 3.2 ± 0.80*** | 3.0 ± 0.88*** | 2.9 ± 0.70*** | 2.9 ± 0.81*** | 2.9 ± 0.86*** | 2.9 ± 0.76*** |
Total BPRS | |||||||||
Year 1 completers | |||||||||
n | 108 | 106 | 102 | 104 | 105 | 95 | 77 | 57 | 33 |
Mean ± s.d | 40.2 ± 11.05 | 33.3 ± 10.08 | 30.7 ± 7.80 | 29.3 ± 7.83 | 29.2 ± 8.27 | 28.7 ± 7.70 | 27.2 ± 7.89 | 26.9 ± 7.01 | 25.5 ± 5.28 |
Year 2 completers | |||||||||
n | 33 | 33 | 32 | 33 | 33 | 33 | 33 | 33 | 33 |
Mean ± s.d | 40.3 ± 13.06 | 34.6 ± 11.91 | 31.5 ± 8.29 | 28.6 ± 6.96 | 30.2 ± 9.66 | 28.2 ± 6.21 | 26.5 ± 5.75 | 26.6 ± 5.62 | 25.5 ± 5.28 |
The total score for SOFAS ranges from 0 to 100. Reported. The CGI-S ranges from 1–7, where a score of 1 indicates no psychopathology and a score of 7 indicates severe psychopathology. The total BPRS ranges from 0–7: 0 = not assessed, 1 = not present, 2 = very mild, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, 7 = extremely severe. Total Score is calculated by adding 18 subscores for each subject at each visit. P value was calculated by using paired t-test of scores at each time point vs baseline defined as time of enrollment into the study. * p < 0.05, *** p < 0.001. BPRS Brief Psychiatric Rating Scale, CGI-S Clinical Global Impression-Severity scale, SOFAS Social and Occupational Functioning Scale