Posted by Tomatheus on September 20, 2015, at 13:51:31
In reply to FDA approves Vraylar - 97 week phase III study, posted by SLS on September 20, 2015, at 5:53:37
> > there are no anecdotes whatsoever about cariprazine
>
> None that have been made readily available, anyway.
>
> Cariprazine acts like Abilify as a dopamine receptor partial agonist. However, it hits D3 receptors harder than D2 receptors when compared to Abilify. It is more selective for D3, and might have more antidepressant effects than Abilify. That is my hope, anyway. I don't know if there are any other advantages to cariprazine. It probably will cause weight gain and some degree of startup akathisia. I hope to find out soon.
>
> Open label protocol:
>
> http://www.prnewswire.com/news-releases/richter-and-actavis-announce-positive-phase-iii-results-for-cariprazine-in-the-prevention-of-relapse-in-patients-with-schizophrenia-300022547.html
>
> "About this Phase III Study
> This 97 week study was a multi-national, multi-center, randomized, double-blind, placebo-controlled clinical trial in adult patients with schizophrenia. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6 or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized to continue their cariprazine dose (3, 6 or 9 mg per day) or switched to placebo for up to 72 weeks or until a relapse occurred. The primary endpoint was time to first symptom relapse during the double blind phase.
>
> In the double-blind phase, there were no cariprazine adverse events >/=10%. Across the cariprazine treated group, the most common adverse events (incidence >/=5% and greater than placebo) were nasopharyngitis, tremor, extrapyramidal disorder, akathisia, back pain, and blood creatine phosphokinase increased."
>
>
> - ScottThank you for posting this information, Scott. Judging from the press release that I posted, it seemed that the only trials that had been conducted on Vraylar were three weeks in length. The study that you made reference to was obviously a lot longer, even though it included an open-label period, and even though patients were ultimately only randomly assigned to receive either Vraylar or placebo if they responded to the medication and met stability criteria after the open-label period. Despite the fact that some might criticize the design of this study, I think it's helpful to see that a lengthy Vraylar trial for schizophrenia was conducted. Do you know if any Vraylar trials exceeding three weeks were conducted for the treatment of bipolar disorder?
Tomatheus
"I need you to show me
The way from crazy
I wanna be so much
More than this"- Jimmy Eat World
poster:Tomatheus
thread:1082598
URL: http://www.dr-bob.org/babble/20150901/msgs/1082734.html