OBJECTIVE: The safety, efficacy, and tolerability of venlafaxine extended release (ER) in subjects ages 7 to 17 years with major depressive disorder were evaluated in two multicenter, randomized, double-blind, placebo-controlled trials conducted between October 1997 and August 2001. METHOD: Participants received venlafaxine ER (flexible dose, based on body weight; intent to treat, n = 169) or placebo (intent to treat, n = 165) for up to 8 weeks. The primary efficacy variable was the change from baseline in the Children's Depression Rating Scale-Revised score at week 8. RESULTS: There were no statistically significant differences between venlafaxine ER and placebo on the Children's Depression Rating Scale-Revised in either study. A post hoc age subgroup analysis of the pooled data showed greater improvement on the Children's Depression Rating Scale-Revised with venlafaxine ER than with placebo (-24.4 versus -19.9; p = .022) among adolescents (ages 12-17), but not among children (ages 7-11). The most common adverse events were anorexia and abdominal pain. Hostility and suicide-related events were more common in venlafaxine ER-treated participants than in placebo-treated participants. There were no completed suicides. CONCLUSIONS: Venlafaxine ER may be effective in depressed adolescents. However, its safety and efficacy in pediatric patients has not been established. Prescribers should monitor for signs of suicidal ideation and hostility in pediatric patients taking venlafaxine ER.
Here are my gripes...
- OK, so the studies were conducted in 1997 and 2001. And they're just getting published NOW? How's that for delaying the bad news? Were the studies positive in their findings, they would have been published years ago.
- Suicidal ideation/suicidal attempt/suicide preparation: 8 of 182 taking venlafaxine, 0 of 179 taking placebo (these numbers come from the latest JAMA analysis, table 3).
- Grasping at straws: One analysis finds that adolescents do a bit better on the drug, and you decide to run with it? Was this finding consistent across various rating scales or was it just one one scale? My initial guess is that the difference was also of a rather small magnitude.