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Last April we reported on Pimavenserin – Nuplazid – the novel antipsychotic that’s FDA approved in psychosis related to parkinson’s disease. In that article we mentioned a randomized controlled trial from Mass General – the CLARITY trial – that showed promising augmentation effects when Pimavenserin was added to an antidepressant in major depressive disorder. Now comes a secondary analysis of that study, which found a significant reduction in anxiety symptoms as well. [Link and Link]

Published On: 10/21/2020

Duration: 3 minutes, 9 seconds

Transcript:

Last April we reported on Pimavenserin – Nuplazid – the novel antipsychotic that’s FDA approved in psychosis related to parkinson’s disease. In that article we mentioned a randomized controlled trial from Mass General – the CLARITY trial – that showed promising augmentation effects when Pimavenserin was added to an antidepressant in major depressive disorder. Now comes a secondary analysis of that study, which found a significant reduction in anxiety symptoms as well. 

This was a large, 5 week, randomized placebo controlled trial of 151 patients with treatment resistant depression who had failed two trials of antidepressants. The original study showed significant improvement on the Hamilton depression scale when  Pimavenserin was added to the antidepressant. This secondary analysis looked at the anxiety/somatization factor of the scale and also saw improvement – with moderate effect size of 0.6. The dose of pimavanserin was 34 mg a day.

The results are encouraging, but need replication, and in the case of anxiety they are only post-hoc results.

Separately, Pimavenserin is pursuing FDA approval in psychosis related to dementia. The company submitted their application to the FDA after their phase 3 HARMONY trial showed that Pimavenserin might reduce the risk of relapse into psychosis in patients with dementia due to various causes – alzheimers, Lewy Body, Parkinson’s, Vascular, and frontal-temporal dementia. That’s encouraging, as those of you who are studying for your board exams will probably recall that antipsychotics are relatively contraindicated in Lewy Body dementia.

Earlier, a phase II study had shown reduction in psychosis in dementia with Pimavenserin compared to placebo after 6 weeks. The new study is a discontinuation study. 351 patients with dementia related psychosis were randomized to stay on or discontinue Pimavenserin after 12 weeks on the drug. The risk of relapse into psychosis was 3 times higher in the ones who came off Pimavenserin.

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