Fact CheckerSign in

NCT06805266Not yet recruitingPhase 4

Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease

An Open Study to Evaluate the Efficacy of Vortioxetine on Freezing of Gait in Patients Affected by Parkinson Disease with Depressive Symptoms

Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
40 (estimated)
First submitted
16 Jan 2025
Start date
Feb 2025
Primary completion date
Dec 2026
Lead sponsor
Marianna Amboni
NCT number
NCT06805266

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 40
  • From Feb 2025 to the primary completion date, Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with IMAO-B (rasagiline, selegiline, safinamide) (to be included, IMAO-B need to be withdrawn for at least 15 days)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
  • Treatment with tramadol or triptans

Other illness

  • Hepatic and renal insufficiency
  • Psychotic disorder
  • Dementia according to DSM-V

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.