Back to Search
Start Over
An Open-Label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults with Parkinson's Disease and Depression.
- Source :
-
Journal of Parkinson's disease [J Parkinsons Dis] 2020; Vol. 10 (4), pp. 1751-1761. - Publication Year :
- 2020
-
Abstract
- Background: Many patients with Parkinson's disease (PD) experience depression.<br />Objective: Evaluate pimavanserin treatment for depression in patients with PD.<br />Methods: Pimavanserin was administered as monotherapy or adjunctive therapy to a selective serotonin reuptake inhibitor or serotonin/noradrenaline reuptake inhibitor in this 8-week, single-arm, open-label phase 2 study (NCT03482882). The primary endpoint was change from baseline to week 8 in Hamilton Depression Scale-17-item version (HAMD-17) score. Safety, including collection of adverse events and the Mini-Mental State Examination (MMSE) and Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) scores, was assessed in patients who received ≥1 pimavanserin dose.<br />Results: Efficacy was evaluated in 45 patients (21 monotherapy, 24 adjunctive therapy). Mean (SE) baseline HAMD-17 was 19.2 (3.1). Change from baseline to week 8 (least squares [LS] mean [SE]) in the HAMD-17 was -10.8 (0.63) (95% CI, -12.0 to -9.5; p < 0.0001) with significant improvement seen at week 2 (p < 0.0001) and for both monotherapy (week 8, -11.2 [0.99]) and adjunctive therapy (week 8,-10.2 [0.78]). Most patients (60.0%) had ≥50% improvement at week 8, and 44.4% of patients reached remission (HAMD-17 score ≤7). Twenty-one of 47 patients experienced 42 treatment-emergent adverse events; the most common by system organ class were gastrointestinal (n = 7; 14.9%) and psychiatric (n = 7; 14.9%). No negative effects were observed on MMSE or MDS-UPDRS Part III.<br />Conclusion: In this 8-week, single-arm, open-label study, pimavanserin as monotherapy or adjunctive therapy was well tolerated and associated with early and sustained improvement of depressive symptoms in patients with PD.
- Subjects :
- Aged
Depression etiology
Drug Therapy, Combination
Female
Humans
Male
Middle Aged
Parkinson Disease complications
Piperidines administration & dosage
Piperidines adverse effects
Serotonin 5-HT2 Receptor Antagonists administration & dosage
Serotonin 5-HT2 Receptor Antagonists adverse effects
Selective Serotonin Reuptake Inhibitors administration & dosage
Selective Serotonin Reuptake Inhibitors adverse effects
Serotonin and Noradrenaline Reuptake Inhibitors administration & dosage
Serotonin and Noradrenaline Reuptake Inhibitors adverse effects
Urea administration & dosage
Urea adverse effects
Urea pharmacology
Depression drug therapy
Outcome Assessment, Health Care
Parkinson Disease drug therapy
Piperidines pharmacology
Serotonin 5-HT2 Receptor Antagonists pharmacology
Selective Serotonin Reuptake Inhibitors pharmacology
Serotonin and Noradrenaline Reuptake Inhibitors pharmacology
Urea analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1877-718X
- Volume :
- 10
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of Parkinson's disease
- Publication Type :
- Academic Journal
- Accession number :
- 32804101
- Full Text :
- https://doi.org/10.3233/JPD-202058