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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03040505
Other study ID # 6527
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 5, 2017
Est. completion date October 20, 2019

Study information

Verified date August 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to investigate temporal organization of future thinking in patients with schizophrenia. Patients and control participants will be asked to envision and briefly describe ten personal future events using a cue-words list. Then they will be asked to describe everything that came to their minds (i.e. to think aloud) while they attempted to determine when an event will likely occur. The investigators will compare the proportion of several predefined strategies mentioned by the two groups of participants to locate future events in time. The investigators predict that patients will envision less personal future events and will rely to a lesser extent on strategies to locate events in time, than control participants.


Recruitment information / eligibility

Status Terminated
Enrollment 56
Est. completion date October 20, 2019
Est. primary completion date October 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnary
Participant's verbalization will be audio recorded and then transcribed by investigators. The investigators will use predefined categories to score the strategies mentioned by participants during the think aloud task.

Locations

Country Name City State
France Service de psychiatrie 1 Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of time location strategies 1 months
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