| Autor: |
Bryan, Dirks, Maurizio, Fava, Sarah D, Atkinson, Mark, Joyce, Michael E, Thase, Becky, Howell, Tim, Lin, Serge, Stankovic |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
Psychopharmacology bulletin. 52(4) |
| ISSN: |
2472-2448 |
| Popis: |
In a phase 2 study, pimavanserin demonstrated efficacy as adjunctive treatment for major depressive disorder (MDD). Subsequently, two phase 3 studies (NCT03968159 in the US; NCT03999918 in Europe) were initiated to examine the efficacy and safety of adjunctive pimavanserin in subjects with MDD and inadequate response to antidepressant treatment. Studies were combined with a prespecified statistical analysis plan owing to recruitment challenges related to the COVID-19 pandemic.The randomized, double-blind studies enrolled 298 patients with MDD and inadequate response to current antidepressants. Patients were randomly assigned 1:1 to pimavanserin or placebo added to current antidepressant for 6 weeks. Primary endpoint was change from baseline to week 5 in the Hamilton Rating Scale for Depression, 17-item version (HAM-D-17).There was no effect of pimavanserin in change from baseline to week 5 in the HAM-D-17 (pimavanserin [n = 138]: least-squares mean [LSM] [standard error {SE}], -9.0 [0.58]; placebo [n = 135]: -8.1 [0.58]; mixed-effects model for repeated measures LSM [SE] difference, -0.9 [0.82],Adjunctive pimavanserin did not significantly improve depressive symptoms, although pimavanserin was well tolerated. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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