The second trial compared duloxetine 60 mg followed by up to 120 mg; duloxetine 30 mg followed by up to 120 mg; fluoxetine 20 mg followed by up to 40 mg; and placebo followed by up to 120 mg duloxetine.
At 10 weeks, the CDRS had fallen by 24.6 points in the duloxetine groups, 22.6 points in the fluoxetine group, and 21.6 points in the placebo group.
By 36 weeks, the CDRS had fallen an additional 7.8 points in the 30 mg duloxetine group; 7.4 points in the 60 mg duloxetine group; and 10 points in the fluoxetine group.
"This is really sad news," Dr. Wagner said. "You just couldn’t make these numbers any closer. Based on the results of these two studies, are we going to see duloxetine approved for children and adolescents? No. Will there be more studies done? Perhaps, but they take a long time to do."
However, she stressed, "even though there was no separation from placebo, some children do respond. Duloxetine still could be an okay choice, but parents need to know these studies were negative."
Dr. Wagner has no financial relationships with pharmaceutical companies.