Parkinson Disease, IdiopathicPhase 4NCT06805266
Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease
A Phase 4 study testing Vortioxetine (tablet) in people with Parkinson Disease, Idiopathic and Freezing of Gait, run by Marianna Amboni.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Idiopathic, Freezing of Gait, Depression Not Otherwise Specified
- What is being tested?
- Vortioxetine (tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Treatment with IMAO-B (rasagiline, selegiline, safinamide) (to be included, IMAO-B need to be withdrawn for at least 15 days)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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open Study to Evaluate the Efficacy of Vortioxetine on Freezing of Gait in Patients Affected by Parkinson Disease with Depressive Symptoms
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.
Read the detailed description
Depression and anxiety are common in patients with Parkinson's disease (PD). In PD, several drugs, such as dopamine-agonists, inhibitors of serotonin uptake (SSRI), tricyclic antidepressants (TCAs) and norepinephrine uptake inhibitors (SNRI) are effective in treating depressive symptoms. Recently, a Delphi consensus has concluded that multimodal drugs, like vortioxetine, are good treatment options for depression in PD and an open-label prospective study has shown that the vortioxetine may improve depressive symptoms and cognition in PD patients with major depression Vortioxetine has different mechanisms of action; it is a serotonin transporter (SERT) inhibitor, an antagonist of 5-HT3, 5-HT7, 5-HTID, a partial agonist of 5-HT1B and a full agonist of 5-HT1A. Moreover, despite vortioxetine does not interact significantly with the norepinephrine transporters or dopamine transporters, it has been shown to increase extracellular levels of norepinephrine, dopamine, and non-monoamine neurotransmitters including acetylcholine. These effects are likely related to the interaction between vortioxetine and various serotonin receptors.
Depression and anxiety or panic attacks are commonly associated to freezing of gait (FOG) in PD. FOG is a disabling symptom of parkinsonian syndromes, whose pathophysiology is heterogeneous and partly unclear. The relationship between FOG and dopaminergic treatment is rather complex. Based on response to dopaminergic treatment, FOG may be responsive, unresponsive (or partially responsive) or induced by dopaminergic drugs. FOG, especially unresponsive FOG, is commonly associated with cognitive dysfunction, namely attentional-executive and visuospatial alterations in PD patients. Since FOG episodes might be related to the Off state and/or to dopaminergic underdosing in PD, the first treatment option should be the increase of dopaminergic drugs dose, when possible. FOG episodes that are less responsive or nonresponsive to dopaminergic treatment represent the greatest therapeutic challenge. Beyond dopaminergic pathway, non-dopaminergic networks, i.e. noradrenergic and cholinergic transmission, may play a role in the pathogenesis of FOG. We hypothesize that vortioxetine might be effective in treating FOG by enhancing both monoamine and non-monoamine neurotransmitters.
STUDY DESIGN Clinical evaluation will be performed during optimal on state of patients
VISIT 1:
- Enrolment: Informed consent signature
- Standardized gait analysis with wearable sensors: Patients will be videotaped and assessed with wearable sensors (Opal) while:
- Performing the Rating Instrument to Assess Festination and Freezing Gait in Parkinsonian Patients (RIAFFGPP) . In RIAFFGPP patients have to:
- Sit down on a chair set up in front of a door. ii. After 30 s, stand up and walk to a floor mark (40 x 40 cm) iii. Perform within the mark two 360° turns, clockwise (cw) and counter-clockwise (ccw) iiii. Open and walk through the door, turn outside, and come back to the chair
- Walking forward along a 10 m path during three conditions:
- self paced velocity ii. fastest as possible without running pace iii. self paced velocity with mental task (seven serial subtraction from 100 - counting aloud)
- Clinical Global Impression scale (patient and clinician)
- FOG Questionnaire referred to the on state
- New freezing of gait questionnaire (NFOG-Q)
- Falls Efficacy Scale
- Cognitive function assessment:
- MMSE
- MoCA
- FiPaT
- Raven Progressive Matrices
- The Benton Judgment of Line Orientation Test (JLOT)
- Rey auditory 15-word learning test
- Babcock story (episodic memory)
- Rey Complex Figure (copy and recall)
- Stroop test
- Trial making test
- Cancellation attentional matrices
- Phonological verbal fluency
- Semantic verbal fluency
- Frontal Assessment Battery
- Constructional Apraxia
- SAND-Denomination
- MDS-UPDRS
- BDI-II
- NPI
- Apathy Scale
- PDQ-8
- Blood pressure, heart rate
- Instruction to fill in a falls diary for the next 2 weeks
VISIT 2 (Start of treatment, after 14 days ± 3 days from Visit 1)
- Enrolled patients will start vortioxetine: Vortioxetine Schedule: Vortioxetine 5 mg: once a day after lunch for one week, After one week, Vortioxetine 10 mg once a day
- Instruction on filling in again a falls diary:
Four weeks after starting medication patients will fill in again a falls diary for the next 2 consecutive weeks
VISIT 3 (after 12 weeks ± 7 days from ):
- Standardized gait analysis with wearable sensors (see visit 1)
- RIAFFGPP
- Walking forward along a 10 m path during three conditions
- Clinical Global Impression scale (patient and clinician)
- FOG Questionnaire
- New freezing of gait questionnaire (NFOG-Q)
- Falls Efficacy Scale
- Cognitive function assessment (see visit 1)
- MDS-UPDRS or
- BDI-II
- NPI
- Apathy Scale
- PDQ-8
- Blood pressure, heart rate
- Adverse events
- Being tested
- Vortioxetine (tablet)
- Keywords
- Parkinson Disease, freezing of gait, depression NOS
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortioxetine (tablet)Drug
Vortioxetine will be used with the aim of treating freezing of gait in subjects with Parkinson Disease and depressive symptoms
| Study group | Role | What they receive |
|---|---|---|
| FOG-PD | Experimental | FOG-PD will receive vortioxetine Receives: Drug: Vortioxetine (tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Change on duration (seconds) of FOG episodes on standardized gait analysis with wearable sensors
Measured: From enrollment to the end of treatment at 12 weeks
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
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marianna Amboni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marianna Amboni, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805266
- Sponsor's protocol ID
- ID:1279VTX - PD-20593T
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical and outcome measures
Publications
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.
PubMed 20310009Santos 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.
PubMed 36358393Nieuwboer 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.
PubMed 19660949Bloem 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.
PubMed 26945525Bang-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.
PubMed 21486038Amboni 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.
PubMed 25899545Amboni 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.
PubMed 18067193Aguera-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.
PubMed 33628415
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study to Evaluate the Efficacy of Vortioxetine on Freezing of Gait in Patients Affected by Parkinson Disease with Depressive Symptoms
- ClinicalTrials.gov ID
- NCT06805266
- Acronym / sponsor ID
- ID:1279VTX - PD-20593T
- Keywords
- Parkinson Disease, freezing of gait, depression NOS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marianna AmboniUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Depression and anxiety are common in patients with Parkinson's disease (PD). In PD, several drugs, such as dopamine-agonists, inhibitors of serotonin uptake (SSRI), tricyclic antidepressants (TCAs) and norepinephrine uptake inhibitors (SNRI) are effective in treating depressive symptoms. Recently, a Delphi consensus has concluded that multimodal drugs, like vortioxetine, are good treatment options for depression in PD and an open-label prospective study has shown that the vortioxetine may improve depressive symptoms and cognition in PD patients with major depression Vortioxetine has different mechanisms of action; it is a serotonin transporter (SERT) inhibitor, an antagonist of 5-HT3, 5-HT7, 5-HTID, a partial agonist of 5-HT1B and a full agonist of 5-HT1A. Moreover, despite vortioxetine does not interact significantly with the norepinephrine transporters or dopamine transporters, it has been shown to increase extracellular levels of norepinephrine, dopamine, and non-monoamine neurotransmitters including acetylcholine. These effects are likely related to the interaction between vortioxetine and various serotonin receptors.
Depression and anxiety or panic attacks are commonly associated to freezing of gait (FOG) in PD. FOG is a disabling symptom of parkinsonian syndromes, whose pathophysiology is heterogeneous and partly unclear. The relationship between FOG and dopaminergic treatment is rather complex. Based on response to dopaminergic treatment, FOG may be responsive, unresponsive (or partially responsive) or induced by dopaminergic drugs. FOG, especially unresponsive FOG, is commonly associated with cognitive dysfunction, namely attentional-executive and visuospatial alterations in PD patients. Since FOG episodes might be related to the Off state and/or to dopaminergic underdosing in PD, the first treatment option should be the increase of dopaminergic drugs dose, when possible. FOG episodes that are less responsive or nonresponsive to dopaminergic treatment represent the greatest therapeutic challenge. Beyond dopaminergic pathway, non-dopaminergic networks, i.e. noradrenergic and cholinergic transmission, may play a role in the pathogenesis of FOG. We hypothesize that vortioxetine might be effective in treating FOG by enhancing both monoamine and non-monoamine neurotransmitters.
STUDY DESIGN Clinical evaluation will be performed during optimal on state of patients
VISIT 1:
- Enrolment: Informed consent signature
- Standardized gait analysis with wearable sensors: Patients will be videotaped and assessed with wearable sensors (Opal) while:
- Performing the Rating Instrument to Assess Festination and Freezing Gait in Parkinsonian Patients (RIAFFGPP) . In RIAFFGPP patients have to:
- Sit down on a chair set up in front of a door. ii. After 30 s, stand up and walk to a floor mark (40 x 40 cm) iii. Perform within the mark two 360° turns, clockwise (cw) and counter-clockwise (ccw) iiii. Open and walk through the door, turn outside, and come back to the chair
- Walking forward along a 10 m path during three conditions:
- self paced velocity ii. fastest as possible without running pace iii. self paced velocity with mental task (seven serial subtraction from 100 - counting aloud)
- Clinical Global Impression scale (patient and clinician)
- FOG Questionnaire referred to the on state
- New freezing of gait questionnaire (NFOG-Q)
- Falls Efficacy Scale
- Cognitive function assessment:
- MMSE
- MoCA
- FiPaT
- Raven Progressive Matrices
- The Benton Judgment of Line Orientation Test (JLOT)
- Rey auditory 15-word learning test
- Babcock story (episodic memory)
- Rey Complex Figure (copy and recall)
- Stroop test
- Trial making test
- Cancellation attentional matrices
- Phonological verbal fluency
- Semantic verbal fluency
- Frontal Assessment Battery
- Constructional Apraxia
- SAND-Denomination
- MDS-UPDRS
- BDI-II
- NPI
- Apathy Scale
- PDQ-8
- Blood pressure, heart rate
- Instruction to fill in a falls diary for the next 2 weeks
VISIT 2 (Start of treatment, after 14 days ± 3 days from Visit 1)
- Enrolled patients will start vortioxetine: Vortioxetine Schedule: Vortioxetine 5 mg: once a day after lunch for one week, After one week, Vortioxetine 10 mg once a day
- Instruction on filling in again a falls diary:
Four weeks after starting medication patients will fill in again a falls diary for the next 2 consecutive weeks
VISIT 3 (after 12 weeks ± 7 days from ):
- Standardized gait analysis with wearable sensors (see visit 1)
- RIAFFGPP
- Walking forward along a 10 m path during three conditions
- Clinical Global Impression scale (patient and clinician)
- FOG Questionnaire
- New freezing of gait questionnaire (NFOG-Q)
- Falls Efficacy Scale
- Cognitive function assessment (see visit 1)
- MDS-UPDRS or
- BDI-II
- NPI
- Apathy Scale
- PDQ-8
- Blood pressure, heart rate
- Adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOG-PD | Experimental | Drug: Vortioxetine (tablet)FOG-PD will receive vortioxetine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetine (tablet)Vortioxetine will be used with the aim of treating freezing of gait in subjects with Parkinson Disease and depressive symptoms | Drug | FOG-PD |
Primary outcome
Change in the score of the Freezing Of Gait (FOG) Questionnaire referred to the "on state"
Time frame: From enrollment to the end of treatment at 12 weeks
Total score of FOG Questionnaire ranges from 0 to 24 and higher scores correspond to more severe FOG
2 secondary outcomes
Change on severity of FOG not responsive to dopaminergic treatment in patients with PD.
Time frame: From enrollment to the end of treatment at 12 weeks
Chenage on frequency of FOG not responsive to dopaminergic treatment in patients with PD.
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 20310009Ziegler 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.
- Background: PubMed 36358393Santos 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.
- Background: PubMed 19660949Nieuwboer 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.
- Background: PubMed 26945525Bloem 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.
- Background: PubMed 21486038Bang-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.
- Background: PubMed 25899545Amboni 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.
- Background: PubMed 18067193Amboni 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.
- Background: PubMed 33628415Aguera-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.
- Individual participant dataSharing planned: Yes. Clinical and outcome measures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine (tablet) in people with Parkinson Disease, Idiopathic and Freezing of Gait, run by Marianna Amboni.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianna Amboni, Professor (+393358274695, mamboni@unisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the score of the Freezing Of Gait (FOG) Questionnaire referred to the "on state" (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06805266, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.