NCT03209778

Brief Summary

Patients with schizophrenia suffer from autobiographical memory disorders. Patients have difficulty to remember vividly personal past events when they are specifically asked for. Indeed, this task requires a good executive functioning to retrieve precise information stored in long term memory. Interestingly, executive functioning has been showed impaired in schizophrenia and studies showed that their autobiographical memory impairments were directed related to their executive dysfunction. Yet, in daily life people remember more often autobiographical memories spontaneously, without trying voluntarily to recall them. In that case, the involuntary recall of personal past events is much less sustained by executive functioning. In this protocol the investigators would like to investigate and compare subjective characteristics of involuntary and voluntary autobiographical memories in order to highlight the role of executive dysfunction in patients' autobiographical memory impairments.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 29, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

July 3, 2017

Last Update Submit

September 13, 2021

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Autobiographical subjective score taking into account memories vividness and specifity

    8 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Control participants without psychiatric nor neurological history

Other: Patients with Schizophrenia

Patients with Schizophrenia

EXPERIMENTAL

Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria

Other: Patients with Schizophrenia

Interventions

Patients with SchizophreniaOTHER

Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria

Control groupPatients with Schizophrenia

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- for patients only
  • male or female
  • age limits : 18-55 years old
  • under the protection of health insurance
  • who have signed up the consent form
  • schizophrenia or schizo-affective disorder according to the DSM-5 criteria (APA, 2013).
  • clinically stable for at least 2 months
  • patients under guardianship or curatorship need agreement of their legal representative
  • informed of the results of prior medical examination for controls only
  • male or female
  • age limits : 18-55 years old
  • under the protection of health insurance
  • who have sign up the consent form
  • recruited from the general population and matched on gender, age years of schooling
  • no psychiatric history (DSM-5)

You may not qualify if:

  • for both patients and controls
  • current severe or unstable somatic illness
  • neurological history (brain injury \> 15 minutes loss of consciousness , epilepsia, brain surgery…)
  • current substance use disorder (DSM-5)
  • current major depressive disorder (CDSS,BDI, HDRS)
  • mental retardation (IQ \< 70, WAIS-4, f-NART)
  • history of general anesthesia 3 months prior to the experiment
  • pregnancy declared by the subject
  • breast feeding
  • current legal control
  • in emergency situation
  • for controls only
  • under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 6, 2017

Study Start

September 29, 2017

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

September 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)