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Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease

ConditionsParkinson Disease, IdiopathicFreezing of GaitDepression Not Otherwise Specified
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

This trial does not accept healthy volunteers

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Treatment with IMAO-B (rasagiline, selegiline, safinamide) (to be included, IMAO-B need to be withdrawn for at least 15 days)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

Design model

Single group

Treatments tested in this trial

  • Vortioxetine (tablet)

    Drug

    Vortioxetine will be used with the aim of treating freezing of gait in subjects with Parkinson Disease and depressive symptoms

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: FOG-PDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Total score of FOG Questionnaire ranges from 0 to 24 and higher scores correspond to more severe FOG

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Change on severity of FOG not responsive to dopaminergic treatment in patients with PD.

Change on duration (seconds) of FOG episodes on standardized gait analysis with wearable sensors

Time frame
From enrollment to the end of treatment at 12 weeks
2

Chenage on frequency of FOG not responsive to dopaminergic treatment in patients with PD.

Change on number of FOG episodes on standardized gait analysis with wearable sensors

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marianna Amboni

Lead sponsor

University of Salerno

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: