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Table 3 Secondary efficacy parameters, full analysis set

From: Randomized, placebo-controlled, adjunctive study of armodafinil for bipolar I depression: implications of novel drug design and heterogeneity of concurrent bipolar maintenance treatments

Time point, statistic Placebo n = 196 Armodafinil 150 mg/day n = 197 P value
LSM change from baseline in IDS-C30 total score
Week 1 −6.1 −5.5 0.3025
Week 2 −10.4 −9.3 0.1940
Week 4 −12.3 −12.5 0.8481
Week 6 −14.2 −16.1 0.0926
Week 7* −16.0 −18.3 0.0492
Week 8 −17.7 −19.6 0.1174
Endpoint −18.3 −19.5 0.3526
LSM change from baseline in QIDS-C16 total score
Week 1 −2.6 −2.4 0.3858
Week 2* −4.5 −3.8 0.0387
Week 4 −5.2 −5.2 0.9978
Week 6 −6.0 −6.5 0.3024
Week 7 −6.7 −7.4 0.1530
Week 8 −7.4 −7.7 0.5471
Endpoint −7.0 −7.1 0.7626
LSM change from baseline in CGI-S score
Week 1 −0.2 −0.2 0.4497
Week 2 −0.5 −0.5 0.9625
Week 4 −0.7 −0.8 0.1467
Week 6* −0.9 −1.2 0.0226
Week 7 −1.1 −1.3 0.0757
Week 8* −1.2 −1.5 0.0159
Endpoint* −1.1 −1.3 0.0320
Proportion of CGI-S responders, n (%)a
Week 1 4 (2) 4 (2) 0.9939
Week 2 15 (8) 16 (8) 0.8927
Week 4 28 (15) 36 (20) 0.2585
Week 6 44 (26) 56 (33) 0.1350
Week 7 55 (32) 68 (40) 0.1031
Week 8 66 (40) 84 (50) 0.0516
Endpoint 67 (34) 86 (44) 0.0503
Week 4* 5.3 7.7 0.0113
Week 8** 11.4 15.2 0.0012
Endpoint** 10.4 13.5 0.0066
  1. CGI-S Clinical Global Impression of Severity of Illness, GAF Global Assessment of Functioning, IDS-C 30 30-Item Inventory of Depressive Symptomatology–Clinician-Rated, LSM least-square mean, QIDS-C 16 16-Item Quick Inventory of Depressive Symptomatology–Clinician-Rated *P<0.05. **P<0.01.
  2. aThe denominator for calculating the percentages at each visit is the number of patients with a non-missing value at that visit. A responder is a patient with a decrease of at least 2 points in severity from baseline in CGI-S rating for depression. The P value for the treatment comparison is from a Cochran-Mantel-Haenszel test, stratified by concurrent mood-stabilizing medication and region of the world