NCT03886584

Brief Summary

the investigators will measure source-monitoring ability in patients with several neuropsychiatric condition and in healthy controls appaired in age, sex and educational level. Source-monitoring will be measured thanks to internal- and reality-monitoring informatic tasks.The investigators hypothesized patients with fronto-temporal abnormalities would show more marked deficits than patients with only frontal abnormalities.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress97%
Mar 2019Jul 2026

Study Start

First participant enrolled

March 8, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

7 years

First QC Date

March 11, 2019

Last Update Submit

July 30, 2025

Conditions

Psychiatric Disorder

Keywords

Bipolar DisorderSource-monitoring

Outcome Measures

Primary Outcomes (1)

  • measure source memory performance

    in patients with neuropsychiatric disorders with or without temporal involvement (pre-dementia Alzheimer's disease, Alzheimer's disease - AD, fronto-temporal dementia - DFT, Lewy body dementia - DCL and bipolar disorder - TBP) and healthy volunteers matched in age, gender, and level of education.

    one year

Secondary Outcomes (1)

  • measure the recognition of distractors

    one year

Study Arms (2)

Patients with with neuropsychiatric conditions

EXPERIMENTAL

In this arm, five groups : * Patients with DFT, diagnosed according Racovsky criteria * Patients with Lewi Body dementia, diagnosed according McKeith criteria * Patients with pre-demential Alzheimer, diagnosed according Dubois criteria * Patients with Alzheimer, diagnosed according MMSE * Patients with bipolar disorder, diagnosed according DSM 5

Other: Monitoring source test

Healthy subjects

ACTIVE COMPARATOR

Healthy controls appaired in age, sex and educational level

Other: Monitoring source test

Interventions

Monitoring source testOTHER

Internal- and external-monitoring correct responses and inversions

Healthy subjectsPatients with with neuropsychiatric conditions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who gave their free and informed consent;
  • Men and women;
  • Aged 18 to 80;
  • Having normal or corrected vision;
  • Mastering the French language (read and spoken);
  • All subjects will not have a working memory deficit preventing the test from being passed (MMSE short version):AM patients should have a score of \<MMSE \<26; Patients with pre-dementia AD will be diagnosed according to Dubois criteria (Dubois et al., 2016); patients with early FTD will be diagnosed according to Rascovsky's criteria (Rascovsky et al., 2011); Patients with DCL will be diagnosed according to McKeith's criteria (McKeith et al., 2005), TBP patients will be diagnosed using DSM 5 criteria (Arlington VA, 2013).

You may not qualify if:

  • Inadmissibility of the consent or refusal of the subject.
  • Patients under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678, France

RECRUITING

MeSH Terms

Conditions

Mental DisordersBipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood Disorders

Study Officials

  • JEROME BRUNELIN, PHD

    Centre Hospitalier Le Vinatier - CRNL - INSERM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JEROME BRUNELIN, PHD

CONTACT

00334 37 91 55 65jerome.brunelin@ch-le-vinatier.fr

Jean-Michel DOREY, PHD

CONTACT

00334 37 91 52 49jean-michel.dorey@ch-le-vinatier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 2 arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 22, 2019

Study Start

March 8, 2019

Primary Completion

March 8, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)