Tolerability, Safety and Efficacy of Vortioxetine

NCT04301492 | Unknown Phase 4 DMC

• 2 other identifiers: VorDe-PD2018-004112-21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Keywords

vortioxetine; tolerability; safety; parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The primary endpoint of this study will be to verify tolerability and safety of vortioxetine in the treatment of sustained depression in PD. The non worsening of motor disability evaluated through Unified Parkinson's Disease Rating Scale (UPDRS) will be the tolerability end point.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Incidence of Vortioxetine in the decrease of depression

  through study completion, an average of 1 year

Study Arms (1)

Vortioxetine

EXPERIMENTAL

first visit medical and pharmacological history will be collected and ECG, laboratory tests and clinical assessment will be performed. After verifying the absence of significant abnormalities at the ECG and laboratory tests and after confirming all inclusion and exclusion criteria, subjects will perform the second visit (Week 1 - Visit 2) to receive study drug (Brintellix drops 20 mg/ml). All subjects will be instructed to take Vortioxetine 1 drop every day after lunch, increasing of 1 drop per day arriving to 10 drops per day. After 5 days from the beginning of treatment, subject will be contacted by phone to check on tolerability and in absence of side effects, the dosage will be increased to 10 drops per day (Visit 3- Phone contact). At Week 4-8-12 (Visits 4-5-6) patients will return to the site to perform all clinical evaluations required and to receive study drug. Visit 7 subjects will return to the site to perform all the assessment required by protocol.

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

16 weeks for each participant. During the first visit a collection of medical and pharmacological history will be collected and ECG, laboratory tests and clinical assessment will be performed. After verifying the absence of significant abnormalities at the ECG and laboratory tests and after confirming all inclusion and exclusion criteria, subjects will perform the second visit to receive study drug (Brintellix drops 20 mg/ml). All subjects will be instructed to take Vortioxetine 1 drop every day after lunch, increasing of 1 drop per day arriving to 10 drops per day. After 5 days from the beginning of treatment, subject will be contacted by phone to check on tolerability and in absence of side effects, the dosage will be increased to 10 drops per day. At Week 4-8-12 patients will return to the site to perform all clinical evaluations required and to receive study drug.

Vortioxetine

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female of every ethnic group, age 30 to 80 years
• Diagnosis of Parkinson's disease according UK Brain Bank Criteria
• Hoehn \&Yahr: stage 1 to 3
• Patients with diagnosis of sustained depression
• Hamilton Depression Rating Scale score (HAM-D-17) ≥ 14
• Beck Depression Inventory score (BDI)≥13
• Stable doses of antiparkinsonian drugs for at least 4 weeks.
• Patients able to understand and provide written informed consent
• Female patients in post-menopausal state with at least one year absence of vaginal bleeding or spotting or be surgically sterile
• Women of childbearing potential must use an acceptable method of contraception
• Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study

You may not qualify if:

• Atypical Parkinsonism.
• Subjects at risk of suicide (with a score ≥ 3 at the Item 3 of the HAM-D-17)
• Any significant psychiatric, metabolic and systemic significant concomitant disease
• Patients with clinically significant out of range laboratory values
• Patients with history of epileptic seizures
• Subjects with Dopa Dysregulation Syndrome (DDS)
• Subjects treated with irreversible IMAO and IMAO-A
• Use of vortioxetine in the past 30 days
• Patient treated with oral anticoagulant
• Patients participating in a clinical trial in the last 6 weeks
• Patients with moderate-severe cognitive decline not able to provide consent form
• Patients currently lactating or pregnant or planning to become pregnant during the duration of the study

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (2)

IRCCS San Raffaele

Roma, 00163, Italy

RECRUITING

IRCCS San Raffaele Roma

Rome, 00163, Italy

RECRUITING

MeSH Terms

Conditions

Depression; Parkinson Disease

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

fabrizio stocchi, MD PhD

CONTACT

+39 0652252311; fabrizio.stocchi@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: March 10, 2020
• Study Start: November 20, 2019
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the end of study
• Access Criteria: request by email

Locations

IT (2)