Not Yet RecruitingPhase 4

Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease

40 participantsStarted 2025-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Treatment with IMAO-B (rasagiline, selegiline, safinamide) (to be included, IMAO-B need to be withdrawn for at least 15 days)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
✕. Psychotic disorder
✕. Dementia according to DSM-V

What they're measuring

Change in the score of the Freezing Of Gait (FOG) Questionnaire referred to the "on state"

Timeframe: From enrollment to the end of treatment at 12 weeks

Trial details

NCT IDNCT06805266

SponsorMarianna Amboni

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Marianna Amboni, Professor

+393358274695 mamboni@unisa.it

View on ClinicalTrials.gov More Parkinson Disease, Idiopathic trials