Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
Study NCT ID:
NCT04301492
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2020-02-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tolerability, Safety and Efficacy of Vortioxetine
Sponsor:
IRCCS San Raffaele Roma
Organization:
Study Overview
Official Title:
Tolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label Study
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VorDe-PD
Brief Summary:
Depression is a psychiatric disorder frequently found in Parkinson's disease (MP), affecting approximately 40-50% of patients and assuming the characteristics of major depression in 17% of cases. Vortioxetine is a new antidepressant, which inaugurates the class of "multimodal" antidepressants, able to exert modulation of serotonergic receptors, inhibit serotonin reuptake, modulate other neurotransmitters such as norepinephrine, dopamine, acetylcholine and histamine.
The primary endpoint of this study will be to verify safety and tolerability of vortioxetine in the treatment of sustained depression in PD. Safety will be assessed through the recording of treatment emergent adverse events (TEAE) and vital signs in each study visits and laboratory tests, ECG, physical and neurological examination at baseline and End of study. The non worsening of motor disability evaluated through Unified Parkinson's Disease Rating Scale (UPDRS) will be the tolerability end point.
The secondary endpoint will be to demonstrate the efficacy on depression: efficacy measures will include Hamilton Depression Rating Scale (HAM-D-17), Beck Depression Inventory (BDI), CGI-S and CGI-I.
The primary endpoint of this study will be to verify safety and tolerability of vortioxetine in the treatment of sustained depression in PD. Safety will be assessed through the recording of treatment emergent adverse events (TEAE) and vital signs in each study visits and laboratory tests, ECG, physical and neurological examination at baseline and End of study. The non worsening of motor disability evaluated through Unified Parkinson's Disease Rating Scale (UPDRS) will be the tolerability end point.
The secondary endpoint will be to demonstrate the efficacy on depression: efficacy measures will include Hamilton Depression Rating Scale (HAM-D-17), Beck Depression Inventory (BDI), CGI-S and CGI-I.
Detailed Description:
Depression is a psychiatric disorder frequently found in Parkinson's disease (MP), affecting approximately 40-50% of patients and assuming the characteristics of major depression in 17% of cases. Depression can also precede the onset of motor symptoms, playing an important role in the clinical course of the disease. Indeed, the presence of depression has been associated with greater disability, a more rapid cognitive decline, a higher mortality and a heavier burden for families and caregivers.The mechanisms underlying depression in MP are still not completely clarified, but autopsy and functional anatomy studies have demonstrated the presence of alterations in the limbic system and in noradrenergic and serotonergic nuclei of the brainstem.This dual nature accounts for the partial ineffectiveness of the common antidepressants that do not target alterations of the dopaminergic system.
Vortioxetine is a new antidepressant, which inaugurates the class of "multimodal" antidepressants, able to exert modulation of serotonergic receptors, inhibit serotonin reuptake, modulate other neurotransmitters such as norepinephrine, dopamine, acetylcholine and histamine.
Currently, tricyclic antidepressants and selective serotonin reuptake inhibitors represent the most common pharmacotherapy for depression treatment in PD patients. Although, they can induce or increase motor disability and other PD symptoms. It is of paramount importance finding a novel therapeutic approach able to positively impact on depression without worsening motor dysfunction. Therefore Vortioxetine can represent an innovative drug in the treatment of depression in PD thanks to its ability to increase dopaminergic neurotransmission in brain structures usually associated with depression.
This is a pilot, single centre, open label, ITT study which will be conducted at the l'IRCCS San Raffaele Pisana, under the responsibility of Fabrizio Stocchi, Principal Investigator.
The study will be conducted in accordance with the guidelines for Good Clinical Practice, in line with the law on the processing of patients' personal data and the principles of the Helsinki Declaration.
Patients will receive informed consent before they are included in the study.
Study population will include patients with idiopathic Parkinson's disease in stage I-III of the disease, suffering from sustained depression. 20 consecutive PD outpatient referred to the center for the study of Parkinson's disease and movement disorders of the IRCCS San Raffaele Pisana will be enrolled.
Since this is a pilot, monocentric study, calculation of the sample size is not required.
Vortioxetine is a new antidepressant, which inaugurates the class of "multimodal" antidepressants, able to exert modulation of serotonergic receptors, inhibit serotonin reuptake, modulate other neurotransmitters such as norepinephrine, dopamine, acetylcholine and histamine.
Currently, tricyclic antidepressants and selective serotonin reuptake inhibitors represent the most common pharmacotherapy for depression treatment in PD patients. Although, they can induce or increase motor disability and other PD symptoms. It is of paramount importance finding a novel therapeutic approach able to positively impact on depression without worsening motor dysfunction. Therefore Vortioxetine can represent an innovative drug in the treatment of depression in PD thanks to its ability to increase dopaminergic neurotransmission in brain structures usually associated with depression.
This is a pilot, single centre, open label, ITT study which will be conducted at the l'IRCCS San Raffaele Pisana, under the responsibility of Fabrizio Stocchi, Principal Investigator.
The study will be conducted in accordance with the guidelines for Good Clinical Practice, in line with the law on the processing of patients' personal data and the principles of the Helsinki Declaration.
Patients will receive informed consent before they are included in the study.
Study population will include patients with idiopathic Parkinson's disease in stage I-III of the disease, suffering from sustained depression. 20 consecutive PD outpatient referred to the center for the study of Parkinson's disease and movement disorders of the IRCCS San Raffaele Pisana will be enrolled.
Since this is a pilot, monocentric study, calculation of the sample size is not required.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-004112-21 | EUDRACT_NUMBER | None | View |