- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040505
Future Mental Projections in Schizophrenia (FutureProSchiz)
August 21, 2023 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Strasbourg, France, 67000
- Service de psychiatrie 1
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
patients with Schizophrenia
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with schizophrenia
Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria
|
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.
|
|
Control participants
- Control participants without psychiatric nor neurological history
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of time location strategies
Time Frame: 1 months
|
1 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2017
Primary Completion (Actual)
October 20, 2019
Study Completion (Actual)
October 20, 2019
Study Registration Dates
First Submitted
January 27, 2017
First Submitted That Met QC Criteria
January 31, 2017
First Posted (Estimated)
February 2, 2017
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 21, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6527
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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