Placebo Outperforms Seroquel In Teen Bipolar Depression Study
A study out recently in Bipolar Disorders shows that Seroquel failed to beat, and was in fact beaten by, placebo in treating depression in 32 adolescents aged 12 to 18 and diagnosed with bipolar disorder type 1 who were given Seroquel for eight weeks or were given placebo:
“Results: There was no statistically significant treatment group difference in change in CDRS-R scores from baseline to endpoint (p = 0.89, effect size =−0.05, 95% confidence interval: −0.77–0.68), nor in the average rate of change over the eight weeks of the study (p = 0.95). Additionally, there were no statistically significant differences in response (placebo =67% versus quetiapine = 71%) or remission (placebo = 40% versus quetiapine = 35%) rates, or change in HAM-A, YMRS, or CGI-BP-S scores (all p > 0.7) between treatment groups. Dizziness was more commonly reported in the quetiapine (41%) than in the placebo (7%) group (Fisher’s exact test, p = 0.04).”
Sixty-seven percent is a high placebo response rate, and the study group is a small one, but then again we keep running across studies of treating teen depression where placebo responses are very high. It’s something researchers have tried to explain away with little success.
I wonder how many teens in this country are being given Seroquel off-label (it’s currently only approved for adult use) for depression and bipolar depression and having a huge placebo response while taking a fat-producing, diabetes-inducing drug.
Oh, yes. The study authors included the University of Cincinnati’s Melissa DelBello (subject of an investigation by Sen. Charles Grassley for undisclosed pharma ties) and Stanford’s Kiki Chang. I don’t think I’ve ever seen either of the pair produce a study that was negative for the study drug, so this is news.
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