Tolerability, Safety and Efficacy of Vortioxetine

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

• • 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 Criteria:

• • 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