Involuntary Memories Investigation in Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients with Schizophrenia
Sponsored by
About this trial
This is an interventional health services research trial for Schizophrenia
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
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
NCT ID
NCT03209778
First Posted
July 3, 2017
Last Updated
September 13, 2021
Sponsor
University Hospital, Strasbourg, France
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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