SchizophreniaFutureProSchizNCT03040505
Future Mental Projections in Schizophrenia
An observational study of Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- questionnary
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2017to 20 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients with Schizophrenia
Who may be able to join
- 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).
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Schizophrenia
- Being tested
- questionnary
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with schizophrenia | Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria Receives: Other: questionnary | |
| Control participants | - Control participants without psychiatric nor neurological history Receives: Other: questionnary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of time location strategies
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start5 Apr 2017
- Primary completion20 Oct 2019
- Study completion20 Oct 2019
Why it stopped: The number of subjects needed was overestimated (from assumptions made in the litterature).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040505
- Sponsor's protocol ID
- 6527
- Acronym
- FutureProSchiz
- Status last verified
- Aug 2023
- First submitted
- 27 Jan 2017
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Mental Projections in Schizophrenia
- ClinicalTrials.gov ID
- NCT03040505
- Acronym / sponsor ID
- FutureProSchiz / 6527
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The number of subjects needed was overestimated (from assumptions made in the litterature).
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | – | Other: questionnaryPatients with schizophrenia or schizoaffective disorder according to DSM-V criteria |
| Control participants | – | Other: questionnary- Control participants without psychiatric nor neurological history |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients with Schizophrenia
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaryParticipant'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. | Other | Control participants, Patients with schizophrenia |
Primary outcome
Number of time location strategies
Time frame: 1 months
Results and safety
The study was stopped early (reason given: The number of subjects needed was overestimated (from assumptions made in the litterature).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The number of subjects needed was overestimated (from assumptions made in the litterature).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of time location strategies (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.