Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3313 for:    schizophrenia

Involuntary Memories Investigation in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209778
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Other: Patients with Schizophrenia Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Involuntary Memories Investigation in Schizophrenia
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Schizophrenia

Arm Intervention/treatment
Active Comparator: Control group
Control participants without psychiatric nor neurological history
Other: Patients with Schizophrenia
Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria

Experimental: Patients with Schizophrenia
Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria
Other: Patients with Schizophrenia
Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria




Primary Outcome Measures :
  1. Autobiographical subjective score taking into account memories vividness and specifity [ Time Frame: 8 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209778


Contacts
Layout table for location contacts
Contact: Fabrice Berna, MD 0033388116462 fabrice.berna@chru-strasbourg.fr

Locations
Layout table for location information
France
Les Hôpitaux Universitaires Recruiting
Strasbourg, France, 67000
Contact: Fabrice Berna, MD       fabrice.berna@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France

Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03209778     History of Changes
Other Study ID Numbers: 6620
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders