Nuvigil: Not Better Than Placebo for Depression Symptoms in Bipolar

Millions of people around the world rely on antidepressants in the treatment of clinical depression and, to a lesser extent, bipolar disorder. Over a dozen such medications exist, and many are also available in generic form.

But for reasons that scientists can’t yet adequately explain, some people don’t respond to many antidepressant drugs. And the drugs they do respond to may carry unwanted side effects that make taking the drug for any length of time downright challenging.

So drug companies are constantly looking for new drugs, new uses for old drugs, and new formulations of old drugs to help improve their batting average. Sadly for this effort, though, we can cross off another potential drug — Nuvigil (armodafinil).

Nuvigil (armodafinil) is an already-existing and FDA-approved drug for the treatment of “excessive sleepiness” due to narcolepsy, shift work, or obstructive sleep apnea. Its not an antidepressant in any traditional sense. Instead it’s something like a stimulant or a “wakefulness-promoting agent.” ((Like its cousin, modafinil, Nuvigil is already prescribed for many of the same reasons — to promote wakefulness in people who are fatigued, can’t concentrate, or feel lethargic.))

Since sleep problems and lethargy are common complaints of people with depressive symptoms, its manufacturer was trying to get an add-on approved treatment for depression symptoms in bipolar I disorder.

The news was released yesterday by the drug’s researchers at Teva Pharmaceuticals. Nuvigil’s final Phase III studies showed statistical significance in “several important secondary endpoints” (which is drug-speak for “the massaged data show some significance, but clinically, you’d be hard pressed to find any benefit”). But it failed to show it was any better than a placebo or sugar pill.

Which is a pretty big deal. In the past few years, drug companies have been called on the carpet for designing studies that underestimate the impact of placebo versus medications (or otherwise cloud the results to minimize placebo data).

Because, as it turns out, the “placebo effect” — being treated with an inactive ingredient — is a pretty big thing in depression. The amount of professional care one receives as well as the simple belief that this pill will help change one’s mood, well, seems to work for some. They get better while taking the placebo.

And as Teva found out, they got better in this study at roughly the same rates as those who were taking the actual medication.

“While this study demonstrated a numerical improvement, we are disappointed that armodafinil did not reach statistical significance. Teva remains committed to advancing science in serious conditions affecting the central nervous system,” said Michael Hayden, Teva’s president of global R&D.

Nuvigil was likely not going to be a blockbuster anyway, because it was an “add on” drug for the treatment of major depression associated with bipolar I disorder. This is a serious area of concern, but it is not an especially large market.

Furthermore, psychiatrists can already prescribe Nuvigil for depressive symptoms associated with bipolar I disorder as an off-label use. So while not shown to be particularly effective, a psychiatrist can still give it a try if warranted.

Read the news release: Teva Reports Top-Line Results from Final Phase III Study of Armodafinil (NUVIGIL®) in Patients with Major Depression Associated with Bipolar I Disorder