Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarianna Amboni
About this trial
The present study involves patients with Parkinson Disease (PD) suffering from freezing of gait (FOG) and depressive symptoms. The main aim of the study is evaluating the efficacy of vortioxetine in reducing moderate/severe FOG not responsive to dopaminergic treatment in patients with PD with depressive symptoms.
Eligibility criteria
Qualifiers
Diagnosis of PD according to published criteria
Occurrence of depression according to Beck Depression Inventory II (score ≥ 15)
A score ≥ 2 on the freezing question #2.13 of part 2 of the MDS-UPDRS (moderate-severe FOG).
FOG not responsive to dopaminergic treatment.
Disqualifiers
Treatment with IMAO-B (rasagiline, selegiline, safinamide) (to be included, IMAO-B need to be withdrawn for at least 15 days)
Concomitant treatment with other antidepressant drugs
Hepatic and renal insufficiency
Treatment with tramadol or triptans
Trial design
Treatments tested in this trial
- Vortioxetine (tablet)
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Marianna Amboni
Lead sponsor
University of Salerno
Sponsor institution
Source ClinicalTrials.gov