Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease

Launched by MARIANNA AMBONI · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called vortioxetine on patients with Parkinson's Disease (PD) who experience both depressive symptoms and a specific issue known as freezing of gait (FOG). FOG is when a person suddenly feels like their feet are glued to the ground, making it difficult to walk. The goal of the study is to see if vortioxetine can help reduce these freezing episodes in patients who are already taking other medications for PD but are still struggling with these symptoms.

To be eligible for the trial, participants need to have a confirmed diagnosis of Parkinson’s Disease and show signs of depression, as measured by a standard questionnaire. They should also have moderate to severe freezing of gait that has not improved with typical PD treatments. However, individuals who are currently taking certain antidepressants or have specific health conditions, such as liver or kidney issues, will not be able to participate. This study is not yet recruiting participants, but once it begins, those who join can expect to be monitored closely for changes in their symptoms while taking the medication.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of PD according to published criteria
• • 2. Occurrence of depression according to Beck Depression Inventory II (score ≥ 15)
• • 3. A score ≥ 2 on the freezing question #2.13 of part 2 of the MDS-UPDRS (moderate-severe FOG).
• • 4. FOG not responsive to dopaminergic treatment.
• Exclusion Criteria:
• • 1. Treatment with IMAO-B (rasagiline, selegiline, safinamide) (to be included, IMAO-B need to be withdrawn for at least 15 days)
• • 2. Concomitant treatment with other antidepressant drugs
• • 3. Hepatic and renal insufficiency
• • 4. Treatment with tramadol or triptans
• • 5. Psychotic disorder
• • 6. Dementia according to DSM-V