Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease

NCT06805266 | Not Yet Recruiting Phase 4

• 1 other identifier: ID:1279VTX - PD-20593T
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parkinson Disease, Idiopathic; Freezing of Gait; Depression Not Otherwise Specified

Keywords

Parkinson Disease; freezing of gait; depression NOS

Outcome Measures

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

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

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

  From enrollment to the end of treatment at 12 weeks

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

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

FOG-PD

EXPERIMENTAL

FOG-PD will receive vortioxetine

Drug: Vortioxetine (tablet)

Interventions

Vortioxetine (tablet) DRUG

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

FOG-PD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Treatment with IMAO-B (rasagiline, selegiline, safinamide) (to be included, IMAO-B need to be withdrawn for at least 15 days)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

Sponsors & Collaborators

• Marianna Amboni: lead

Related Publications (8)

• Ziegler K, Schroeteler F, Ceballos-Baumann AO, Fietzek UM. A new rating instrument to assess festination and freezing gait in Parkinsonian patients. Mov Disord. 2010 Jun 15;25(8):1012-8. doi: 10.1002/mds.22993.

  PMID: 20310009 BACKGROUND

• Santos Garcia D, Alonso Losada MG, Cimas Hernando I, Cabo Lopez I, Yanez Bana R, Alonso Redondo R, Paz Gonzalez JM, Cores Bartolome C, Feal Painceiras MJ, Iniguez Alvarado MC, Labandeira C, Garcia Diaz I. Vortioxetine Improves Depressive Symptoms and Cognition in Parkinson's Disease Patients with Major Depression: An Open-Label Prospective Study. Brain Sci. 2022 Oct 29;12(11):1466. doi: 10.3390/brainsci12111466.

  PMID: 36358393 BACKGROUND

• Nieuwboer A, Rochester L, Herman T, Vandenberghe W, Emil GE, Thomaes T, Giladi N. Reliability of the new freezing of gait questionnaire: agreement between patients with Parkinson's disease and their carers. Gait Posture. 2009 Nov;30(4):459-63. doi: 10.1016/j.gaitpost.2009.07.108. Epub 2009 Aug 5.

  PMID: 19660949 BACKGROUND

• Bloem BR, Marinus J, Almeida Q, Dibble L, Nieuwboer A, Post B, Ruzicka E, Goetz C, Stebbins G, Martinez-Martin P, Schrag A; Movement Disorders Society Rating Scales Committee. Measurement instruments to assess posture, gait, and balance in Parkinson's disease: Critique and recommendations. Mov Disord. 2016 Sep;31(9):1342-55. doi: 10.1002/mds.26572. Epub 2016 Mar 4.

  PMID: 26945525 BACKGROUND

• Bang-Andersen B, Ruhland T, Jorgensen M, Smith G, Frederiksen K, Jensen KG, Zhong H, Nielsen SM, Hogg S, Mork A, Stensbol TB. Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder. J Med Chem. 2011 May 12;54(9):3206-21. doi: 10.1021/jm101459g. Epub 2011 Apr 12.

  PMID: 21486038 BACKGROUND

• Amboni M, Stocchi F, Abbruzzese G, Morgante L, Onofrj M, Ruggieri S, Tinazzi M, Zappia M, Attar M, Colombo D, Simoni L, Ori A, Barone P, Antonini A; DEEP Study Group. Prevalence and associated features of self-reported freezing of gait in Parkinson disease: The DEEP FOG study. Parkinsonism Relat Disord. 2015 Jun;21(6):644-9. doi: 10.1016/j.parkreldis.2015.03.028. Epub 2015 Apr 13.

  PMID: 25899545 BACKGROUND

• Amboni M, Cozzolino A, Longo K, Picillo M, Barone P. Freezing of gait and executive functions in patients with Parkinson's disease. Mov Disord. 2008 Feb 15;23(3):395-400. doi: 10.1002/mds.21850.

  PMID: 18067193 BACKGROUND

• Aguera-Ortiz L, Garcia-Ramos R, Grandas Perez FJ, Lopez-Alvarez J, Montes Rodriguez JM, Olazaran Rodriguez FJ, Olivera Pueyo J, Pelegrin Valero C, Porta-Etessam J. Focus on Depression in Parkinson's Disease: A Delphi Consensus of Experts in Psychiatry, Neurology, and Geriatrics. Parkinsons Dis. 2021 Feb 8;2021:6621991. doi: 10.1155/2021/6621991. eCollection 2021.

  PMID: 33628415 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

Vortioxetine; Tablets

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Marianna Amboni, Professor

CONTACT

+393358274695; mamboni@unisa.it

Federico Di Filippo, Doctor

CONTACT

+393519398297; federicodifilippo@hotmail.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 3, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For 12 months after the completation of the study
• Access Criteria: contacting Central Contact Person by email on mamboni@unisa.it