NCT02824367

Brief Summary

Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer of depression and / or anxiety.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

October 6, 2014

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

April 22, 2014

Last Update Submit

August 20, 2018

Conditions

Keywords

ParkinsonPerfectionism

Outcome Measures

Primary Outcomes (2)

  • Perfectionism evaluation 1

    Scores to perfectionism scales (Frost Multidimensional Perfectionism Scales (FMPS)

    Day 0

  • Perfectionism evaluation 2

    Hewitt Multidimensional Perfectionism Scale (HMPS).

    Day 0

Secondary Outcomes (2)

  • Depression and anxiety evaluation 1

    Day 0

  • Depression and anxiety evaluation 2

    Day 0

Study Arms (2)

Parkinsonian

OTHER

Patient Arm: Parkinsonian will complete several scale of evaluation. Behavioral: Completion of scales evaluation

Behavioral: Completion of scales evaluation

Dystonic

OTHER

Comparator Arm: Dystonic patient will complete several scale of evaluation. Behavioral: Completion of scales evaluation

Behavioral: Completion of scales evaluation

Interventions

Patient complete scores to perfectionism scales (Frost Multidimensional Perfectionism Scales (FMPS), Hewitt Multidimensional Perfectionism Scale (HMPS), scores to depression scale (Beck Depression Inventory (BDI)) and anxiety scale (State Trait Anxiety Inventory (STAI))

DystonicParkinsonian

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years
  • Score Mini Mental Scale (MMS) greater than 23
  • For Parkinsonian, Parkinson disease be defined according to the criteria of the Unified Parkinson Disease Rating Scale (UPDRS), with a Hoehn and Yahr stage 1, 2 or 3
  • The control patients present dystonias not within the scope of Parkinson
  • Informed Consent Form signed
  • Patient covered by social insurance

You may not qualify if:

  • Proven Presence of neuropsychological disorders
  • Patients with deep brain stimulation
  • Diagnosis of somatic pathology diagnosed
  • Private Patient freedom or protected adult (under guardianship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Pierre KRYSTKOWIAK, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

July 6, 2016

Study Start

October 6, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations