Late coming into this thread I know. On your opening post you mentioned you were on day 3 of treatment. Still ongoing?
Regarding Caplyta, it has shown promise as an adjunctive treatment for treatment resistance depression (TRD) .Clinical trials investigating its use in this context began gaining attention around 2023-2024, with promising results from Phase 3 studies showing its effectiveness when combined with antidepressants. These studies demonstrated significant reductions in depressive symptoms over six weeks, suggesting its potential as a valuable option for TRD. For example, in a Phase 3 study, a 42 mg daily dose of Caplyta significantly reduced depressive symptoms compared to placebo, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) over six weeks.
The results suggest that Caplyta could be a valuable option for individuals who haven't responded well to traditional antidepressants. However, its use in TRD is still under evaluation, and approval for this specific indication may depend on further studies and regulatory decisions.
Regarding your question about how common off-label drug use (OLDU) is. It's quite common - at least over here in the UK. OLDU can have a broad coverage from an indication for an unlicensed use, to something as mundane as splitting a tablet in half - yes I kid you not.
I see that some....... interesting views has been expressed about OLDU on this thread . Allow me to address some of them :
1. "One of the problems with off-label prescription is that often times drug companies have pushed off-label uses of their drugs to boost sales when no beneficial effect exists. "
It's actually illegal for drug companies to promote/advertise off license use for their drugs. To do so would just leave them open to a world of financial pain Having said that yes there has been cases where some rogue operatives have attempted to cross the line.
2. "On the other hand, sometimes a beneficial effect of a drug is discovered after the patent has expired, and no one has a financial incentive to pay for the very lengthy process of getting a drug FDA approved for a certain condition. So off-label uses of a drug generally seem shaky to me if the drug is still under patent. "
It is common for the additional beneficial effects of a drug to be discovered before patent expiry. Gabapentin, Lyrica being prime examples. In fact if OLDU is enacted before patent expiry, then it can be used as an attempt to extend the patency life or at least leverage to block or hamper the release of the generic equivalent by rival manufacturers. If I may also add, whether a manufacturer wishes to apply for licensing approval for a specificcondition in whatever country they are operating in, a key driver would naturally be the size of the customer base they are targeting and whether it'd be financially worthwhile.
It sounds to me like the notion it's going to help with TRD is entirely speculative. Unless there's a study, even a small one, indicating that this drug may treat TRD, it's completely a crap shoot. It's understandable that your doctor might want to explore some unusual options if standard treatments aren't helping, but I'd recommend getting a second opinion. There's no solid indication that this drug is going to be either safe or effective.
OLDU is not some random practice. it’s often grounded in a well-documented clinical rationale. Prescribers typically rely on evidence from studies, clinical trials, or expert consensus to justify using a medication outside its licensed indications. With Caplyta and based on it's unique mechanism of action targeting several neurotransmitter systems in the brain there is sound reasoning for the possible use of this as an adjunctive treatment. This drug is classified as an aytpical antipsychotic and other meds in this class, like aripiprazole or quetiapine have themselves been established as off-label use to augment antidepressants. Wee bit disingeneous to say that "your doctor may wish explore some unusual options...."
For off licence use in general, it may be worth pointing out that there are guidelines should a prescriber wish to go down this path. They are expected to consider the risk to basic benefit ratio and to make such considerations on an individual patient basis. Worth highlighting also that with OLDU, liability will shift from the manufacturer to the prescriber and possibily to the dispensing pharmacist as well. One such deterrent to swerve prescribing with reckless abandon.
