Table 2.
Key Outcomes at 12 Weeks*
| Assessment Scale and Week of Evaluation | Combination Therapy (N=140) | Sertraline (N=133) | Cognitive Behavioral Therapy (N=139) | Placebo (N=76) |
|---|---|---|---|---|
| Clinical Global Impression-Improvement scale — % with response to therapy (95% CI)† | ||||
| Baseline | NA | NA | NA | NA |
| Week 4 | 21.4 (15.4-29.0) | 18.8 (13.0-18.8) | 9.3 (5.5-15.5) | 6.6 (2.6-14.9) |
| Week 8 | 54.3 (46.0-62.3) | 47.4 (39.1-55.8) | 29.5 (22.6-37.6) | 22.4 (14.4-33.1) |
| Week 12 | 80.7 (73.3-86.4) | 54.9 (46.4-63.1) | 59.7 (51.4-67.5) | 23.7 (15.5-34.5) |
| Score on Pediatric Anxiety Rating Scale — mean (95% CI)‡§ | ||||
| Baseline | 19.4±3.9 (18.8-20.1) | 18.8±3.9 (18.1-19.4) | 18.9±3.9 (18.2-19.6) | 19.6±3.9 (18.7-20.5) |
| Week 4 | 14.6±3.9 (14.0-15.3) | 14.2±4.0 (13.6-14.9) | 16.0±3.9 (15.4-16.7) | 16.0±4.1 (15.0-16.9) |
| Week 8 | 10.6±4.9 (9.8-11.4) | 11.2±5.0 (10.4-12.1) | 13.3±4.8 (12.5-14.1) | 13.6±5.2 (12.5-14.8) |
| Week 12 | 7.4±6.0 (6.4-8.4) | 9.8±6.2 (8.7-10.8) | 10.8±5.9 (9.8-11.7) | 12.6±6.3 (11.2-14.0) |
| Score on Clinical Globe Impressions-Severity — mean (95% CI)§¶ | ||||
| Baseline | 5.1±0.7 (5.0-5.2) | 5.0±0.7 (4.8-5.1) | 5.0±0.7 (4.9-5.1) | 5.1±0.7 (5.0-5.3) |
| Week 4 | 4.2±0.8 (4.0-4.3) | 4.1±0.8 (4.0-4.2) | 4.5±0.8 (4.4-4.6) | 4.4±0.8 (4.2-4.6) |
| Week 8 | 3.3±1.0 (3.1-3.4) | 3.5±1.0 (3.3-3.6) | 3.9±1.0 (3.7-4.1) | 4.0±1.1 (3.7-4.2) |
| Week 12 | 2.4±1.3 (2.2-2.7) | 3.0±1.3 (2.8-3.2) | 3.3±1.3 (3.1-3.5) | 3.8±1.4 (3.5-4.1) |
| Score on Children’s Global Assessment Scale — mean (95% CI)§∥ | ||||
| Baseline | 50.5±7.0 (49.3-51.7) | 50.9±7.0 (49.7-52.1) | 51.0±7.1 (49.8-52.1) | 50.1±7.0 (48.5-51.6) |
| Week 4 | 56.2±6.7 (55.1-57.4) | 56.8±6.9 (55.6-57.9) | 54.3±6.7 (53.1-55.4) | 54.6±7.0 (53.0-56.2) |
| Week 8 | 62.3±8.3 (60.9-63.6) | 61.4±8.5 (60.0-62.9) | 58.5±8.2 (57.2-59.9) | 58.0±8.7 (56.0-59.9) |
| Week 12 | 68.6±10.4 (66.9-70.3) | 65.0±10.7 (63.1-66.8) | 63.8±10.2 (62.1-65.5) | 60.1±10.9 (57.7-62.6) |
Plus-minus values are means ±SD. All analyses were performed on data from the intention-to-treat population. Primary outcome variables were scores on the Clinical Global Impression-Improvement scale and the Pediatric Anxiety Rating Scale. NA denotes not applicable.
Values are the proportion of subjects who had a response to therapy, which was defined as a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale, which ranges from 1 to 7, with lower scores indicating more improvement, as compared with baseline.
Scores on the Pediatric Anxiety Rating Scale range from 0 to 30, with scores higher than 13 consistent with moderate levels of anxiety and a diagnosis of an anxiety disorder.
Values are expected mean scores, which were determined by linear mixed-effects model analysis.
Scores on the Clinical Global Impression-Severity scale range from 1 to 7, with higher scores indicating greater severity of the disorder.
Scores on the Children’s Global Assessment Scale range from 1 to 100, with lower scores indicating greater impairment. Scores of 60 or lower are considered to indicate a need for treatment, and a score of 50 corresponds to moderate impairment that affects most life situations and is readily observable.