Risperdal For Depression Study Looks Pretty Bogus

I referred the other day to a new study claiming that Risperdal was efficacious for use in treatment resistant depression, knowing full well that CL Psych and others would poke into and deliver the goods. Did they ever.

From CL Psych:

"Not to be a stickler for details, but at the end of Week 1, the average patient on Risperdal was 1.5 points better off on the HAM-D (see above) compared to the average patient on placebo. Yes, it's statistically significant, but it's pretty close to meaningless. Oh, and at week 2, the difference had shrunk to 1.2 points and was no longer statistically significant. So how did "the magnitude of benefit appear to increase steadily throughout the study" when the benefit decreased from week 1 to week 2? The benefit of risperidone over placebo did improve from a measly 1.9 points on the HAM-D at week 4 to a questionably meaningful 2.8 points at week 6 -- not sure that is a steadily increasing benefit worthy of much mention."

Ahem.

CL Psych also caught something else interesting in the study:

"I was hoping they'd mention Invega (paliperidone), the Son of Risperdal and I was not disappointed. As you likely know, Invega is the patent extender for Janssen, as generic risperidone will soon make branded Risperdal into a has-been. This is clearly an attempt to link the present study's modestly positive results to Invega. You can bet your life savings that Janssen reps will be pounding down doors attempting to convince docs that Invega is just like Risperdal but better because of some trumped-up advantages, which will include some of the "hypothetical advantages" mentioned above. So the study, published in a highly respected journal, goes to show that a product just like Invega works as an antidepressant, but Invega gives you the efficacy of Risperdal in a new, improved formulation."

In other words, researchers didn't test Invega on patients in this study, but since it is something of a molecular riff on Risperdal they hypothesized that it might have advantages too, however small. That is the kind of logic that deservedly earns students low marks on terms papers and would get a student kicked out of a chemistry lab class. Stunning that allegedly professional researchers would engage in such marketing hype.

Dr. Shock also has some thoughts on the study:

"The difference between mean score on the Hamilton Deression Rating Scale for the risperidone group and placebo group was only 1.9. The authors deemed 3 points clinical relevant.

"If there is really an effect it is very small and clinically irrelevant. Moreover it means loosing time before using a more evidence based strategy such as lithium addition."

Dr. Shock has concluded in another post:

"Use of antipsychotics for psychotic depression especially on the long term is not evidence based. It obscures diagnoses and treatment outcome leading to omission of other effective treatments in order to obtain remission for psychotic depression."

I concur.