Status:
UNKNOWN
Tolerability, Safety and Efficacy of Vortioxetine
Lead Sponsor:
IRCCS San Raffaele Roma
Conditions:
Depression
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
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. Vort...
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. Depr...
Eligibility Criteria
Inclusion
- • 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
Exclusion
- • 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
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04301492
Start Date
November 20 2019
End Date
July 30 2023
Last Update
June 22 2023
Active Locations (2)
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1
IRCCS San Raffaele
Roma, Italy, 00163
2
IRCCS San Raffaele Roma
Rome, Italy, 00163