NCT03338179

Brief Summary

The purpose of this study is to determine the respective roles of aging and schizophrenia in the regulation of metamemory using a generation strategy. 4 groups will be necessary to comparison: Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 59.5 years) Aged controls (≥ 59.5 years) The effects of age and the disease could lead to interaction in regulating metamemory. The effect of age would be aggravated by the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 8, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

5.3 years

First QC Date

November 7, 2017

Last Update Submit

November 10, 2017

Conditions

SchizophreniaAging

Keywords

MetamemorySchizophrenia

Outcome Measures

Primary Outcomes (1)

  • difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) using a generation strategy.

    the 4 groups of participants formed by the case-control study in two age strata value their judgments of learning for each pair of words using a 5 point scale (0%, 25%, 50%, 75%, 100%) with the generation strategy.

    at day 1

Secondary Outcomes (3)

  • Difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) between generation and reading strategies

    at day 1

  • Difference of number of recalled word using a generation strategy

    at day 1

  • Difference of number of recalled word between generation and reading strategies

    at day 1

Study Arms (4)

Adult Patients

EXPERIMENTAL

Schizophrenia patients aged between 18 and 45 years old

Behavioral: Judgement of learning evaluation

Aged Patients

EXPERIMENTAL

Schizophrenia patients aged 59.5 years and above

Behavioral: Judgement of learning evaluation

Adult Controls

ACTIVE COMPARATOR

Controls aged between 18 and 45 years old

Behavioral: Judgement of learning evaluation

Aged Controls

ACTIVE COMPARATOR

Controls aged 59.5 years and above

Behavioral: Judgement of learning evaluation

Interventions

Judgement of learning evaluationBEHAVIORAL

The hardware consists of two lists of 30 pairs of French words, each pair of words being composed of a word index and a target word (names of concrete objects). Among the 60 word pairs, 30 are strongly associated items (or easy items, the other 30 being weakly associated or difficult items.

Adult ControlsAdult PatientsAged ControlsAged Patients

Eligibility Criteria

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

You may qualify if:

  • For both:
  • Age: between 18 and 45 years for adults, and 59.55 and above for older,
  • For patients :
  • DSM-5 criteria of schizophrenia
  • Adult patients (\<45 years) will be matched to elderly patients (\> 59.55 years) gender and educational level,
  • Patients followed as outpatients,
  • Age of onset of the disease less than 40 years,
  • Patients whose disease has stabilized: no changes psychotropic treatment for at least 1 month
  • Not more of a benzodiazepine,
  • Patients on protection of justice or not,
  • For controls :
  • \- Matched for sex to patient
  • Age-matched (+/- 3 years) to patient
  • Matched for educational level (+/- 2 years) to patients

You may not qualify if:

  • For patients :
  • Any other comorbid psychiatric diagnosis of Axis I DSM-5 (particularly depression, addiction excluding tobacco, dementia)
  • Patients with impaired vision or hearing preventing the realization of the tests.
  • Long-term Anticholinergic treatment.
  • Patients with less 5 years of school
  • For controls:
  • Any psychiatric diagnosis according to DSM-5, including addictions (excluding tobacco)
  • Head injuries, brain injuries or diseases,
  • vision or hearing problems preventing the realization of the tests.
  • Current or past addiction to all toxic substances except tobacco.
  • Long-term Anticholinergic treatment.
  • Related to the first degree diagnosed with a psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Isabelle JALENQUES

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
no masking
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

February 8, 2011

Primary Completion

May 23, 2016

Study Completion

May 23, 2016

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

FR(1)