SchizophreniaSelf and TimeNCT02765880
Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders
A study testing fMRI and EEG in people with Schizophrenia and Bipolar Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- fMRI and EEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2017to 1 Jul 2025
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 60 years
- Affiliation to a social security insurance
- Written consent given
- Only for patient : DSM criteria for schizophrenia or bipolar disorder
Who cannot join
- Addiction problem
- Invalidating visual sensory problems
- Neurological history
- Pregnancy or breastfeeding
- Legal safeguard
- Participation in another clinical trial
- Contraindication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- fMRI, EEG
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Connectivity between the areas related to information processing over time and the areas activated during the rest activity. We will verify whether the activation anomalies observed during time tasks predict anomalies in spontaneous activity dynamics.
EEGOther
link between EEG response anomalies related to information processing over time and response anomalies recorded during rest activity. We will check whether anomalies in EEG oscillatory responses during time tasks predict anomalies during the rest task.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Experimental | Not described Receives: Other: fMRI; Other: EEG |
| Patients with schizophrenia | Experimental | Not described Receives: Other: fMRI; Other: EEG |
| Patient with bipolar disorder | Experimental | Not described Receives: Other: fMRI; Other: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormalities in connectivity during order judgement tasks will be taken as seeds to check whether they account for abnormalities in connectivity at rest, by means of mathematic modelization
Measured: After study completion (2 years)
Secondary outcomes (3)
Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during rest.
Measured: After study completion (2 years)
- Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during time ordering.
Measured: After study completion (2 years)
Comparison of patients with schizophrenia vs. bipolar disorder
Measured: During fMRI and EEG sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study start16 Mar 2017
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Why it stopped: not enough patients avalaible
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale
- Responsible party
- Sponsor
- Investigators
- Anne GIERSCH, Principal investigator, Strasbourg's University Hospitals - INSERM 1114 Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765880
- Sponsor's protocol ID
- 6366
- Acronym
- Self and Time
- Status last verified
- Aug 2025
- First submitted
- 15 Apr 2016
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders
- ClinicalTrials.gov ID
- NCT02765880
- Acronym / sponsor ID
- Self and Time / 6366
- Conditions
- Schizophrenia, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients avalaible
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 9 May 2016 (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 main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Experimental | Other: fMRI, Other: EEG |
| Patients with schizophrenia | Experimental | Other: fMRI, Other: EEG |
| Patient with bipolar disorder | Experimental | Other: fMRI, Other: EEG |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 60 years
- Affiliation to a social security insurance
- Written consent given
- Only for patient : DSM criteria for schizophrenia or bipolar disorder
Key exclusion criteria (7 listed)
- Addiction problem
- Invalidating visual sensory problems
- Neurological history
- Pregnancy or breastfeeding
- Legal safeguard
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 |
|---|---|---|
| fMRIConnectivity between the areas related to information processing over time and the areas activated during the rest activity. We will verify whether the activation anomalies observed during time tasks predict anomalies in spontaneous activity dynamics. | Other | Healthy volunteer, Patient with bipolar disorder, Patients with schizophrenia |
| EEGlink between EEG response anomalies related to information processing over time and response anomalies recorded during rest activity. We will check whether anomalies in EEG oscillatory responses during time tasks predict anomalies during the rest task. | Other | Healthy volunteer, Patient with bipolar disorder, Patients with schizophrenia |
Primary outcome
Abnormalities in connectivity during order judgement tasks will be taken as seeds to check whether they account for abnormalities in connectivity at rest, by means of mathematic modelization
Time frame: After study completion (2 years)
3 secondary outcomes
Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during rest.
Time frame: After study completion (2 years)
- Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during time ordering.
Time frame: After study completion (2 years)
Comparison of patients with schizophrenia vs. bipolar disorder
Time frame: During fMRI and EEG sessions
Results and safety
The study was stopped early (reason given: not enough patients avalaible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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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.
Anne GIERSCH principal investigator
Strasbourg's University Hospitals - INSERM 1114 Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI and EEG in people with Schizophrenia and Bipolar Disorder, 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 4 inclusion and 7 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 19 Aug 2025. 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: not enough patients avalaible). 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?
Abnormalities in connectivity during order judgement tasks will be taken as seeds to check whether they account for abnormalities in connectivity at rest, by means of mathematic modelization (time frame: After study completion (2 years)). 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 19 Aug 2025.