Future Mental Projections in Schizophrenia | NCT03040505

Studies
Future Mental Projections in Schizophrenia

NCT03040505

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Aug 23, 2023Actual

Enrollment

56Actual

Phase

Not provided

Conditions

Schizophrenia

Interventions

questionnary

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The number of subjects needed was overestimated (from assumptions made in the litterature).

Expanded Access Info

Start Date

Apr 5, 2017Actual

Primary Completion Date

Oct 20, 2019Actual

Completion Date

Oct 20, 2019Actual

First Submitted Date

Jan 27, 2017

First Submission Date that Met QC Criteria

Jan 31, 2017

First Posted Date

Feb 2, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2023

Last Update Posted Date

Aug 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with schizophrenia		Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria	Other: questionnary
Control participants		- Control participants without psychiatric nor neurological history	Other: questionnary

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnary	Other	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.

Measure	Description	Time Frame
Number of time location strategies		1 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

patients with Schizophrenia

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Service de psychiatrie 1		Strasbourg		67000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders