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Involuntary Memories Investigation in Schizophrenia

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients with Schizophrenia
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • - 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)

Exclusion Criteria:

  • 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
  • included during exclusion period in another experiment
  • for controls only
  • taking of antipsychotic drugs for the 3 weeks prior to inclusion
  • under guardianship or curatorship

Sites / Locations

  • Les Hôpitaux Universitaires

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Patients with Schizophrenia

Arm Description

Control participants without psychiatric nor neurological history

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

Outcomes

Primary Outcome Measures

Autobiographical subjective score taking into account memories vividness and specifity

Secondary Outcome Measures

Full Information

First Posted
July 3, 2017
Last Updated
September 13, 2021
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03209778
Brief Title
Involuntary Memories Investigation in Schizophrenia
Official Title
Involuntary Memories Investigation in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
The research was stopped because of recruitment difficulties at the end of the study due to a high drop-out rate for one of the two tasks included in the protocol.
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control participants without psychiatric nor neurological history
Arm Title
Patients with Schizophrenia
Arm Type
Experimental
Arm Description
Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria
Intervention Type
Other
Intervention Name(s)
Patients with Schizophrenia
Intervention Description
Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria
Primary Outcome Measure Information:
Title
Autobiographical subjective score taking into account memories vividness and specifity
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 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) Exclusion Criteria: 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 included during exclusion period in another experiment for controls only taking of antipsychotic drugs for the 3 weeks prior to inclusion under guardianship or curatorship
Facility Information:
Facility Name
Les Hôpitaux Universitaires
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Involuntary Memories Investigation in Schizophrenia

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