Severe Psychiatric DisordersPSYCOGNCT05025566
Cognitive Phenotyping of Severe Psychiatric Disorders (PSYCOG)
An observational study of Severe Psychiatric Disorders, run by University Hospital, Grenoble.
Trial summary
The identification of transnosographic dimensions constituted by cognitive disorders constitutes a particularly promising avenue for classifying psychiatric disorders in a more precise and personalized manner. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Psychiatric Disorders
- What is being tested?
- Cognitive (behavioural and neurophysiological) screening
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study Population : Patients with Severe Psychiatric Disorders (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder) Control Population : Healthy volunteers
Who may be able to join
- 18 to 65 years of age,
- Suffering from a severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder),
- Benefiting from cognitive phenotyping (neuropsychological assessment and possibly EEG) as part of the initial assessment for a severe psychiatric disorder, proven non-opposition to participation in the study, ability to perform cognitive tests: speaking and understanding French easily, presence of an identified support person, absence or presence of a property protection measure such as curatorship or guardianship
- ages 18 to 65,
- proven non-opposition to participating in the study,
- ability to perform cognitive tests: able to speak and understand French
Who cannot join
- impossible to collect information on exposure (subjects recently arrived in France, foreign language ...),
- history of coma, epilepsy, head trauma with loss of consciousness over 10 minutes, scalp pathology,
- subject included in another clinical and/or therapeutic experiment in progress involving the testing of a therapeutic treatment or a drug treatment,
- opposition to participation in research,
- inability to perform cognitive tests: non-psychiatric (somatic) condition likely to affect cognitive abilities, sensory or peripheral motor deficits, clinical condition in acute phase (agitation, altered consciousness),
- protection of property measure such as safeguard of justice,
- For healthy volunteers only: past or current severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cognitive Phenotyping of Severe Psychiatric Disorders
The identification of transnosographic dimensions constituted by cognitive disorders constitutes a particularly promising avenue for classifying psychiatric disorders in a more precise and personalized manner. However, despite interesting preliminary data, there is no exhaustive phenotyping of the different cognitive disorders in large samples where all severe psychiatric disorders are represented. Moreover, the brain mechanisms underlying cognitive disorders remain poorly understood, whereas their identification would allow a better understanding of the pathophysiology of these disorders as well as the identification of potential therapeutic targets.
Here, the investigators will compare cognitive-behavioral performance in patients with different types of severe psychiatric disorders (psychotic disorders, depressive disorders, bipolar disorder, anxiety disorders, autism spectrum disorders and eating disorders) and healthy volunteers to identify specific and shared cognitive alterations between the different severe psychiatric disorders. In addition, the investigators will compare neurophysiological cognitive data in to identify alterations in neurophysiological cognitive mechanisms that are specific to and shared between the different severe psychiatric disorders.
Read more
The investigators will include 180 patients suffering from a severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder) and benefiting from cognitive phenotyping (neuropsychological assessment and possibly EEG) as part of the initial assessment for a severe psychiatric disorder. In parallel, the investigators will include 180 healthy volunteers The different variables corresponding to the judgment criteria will be compared between the groups by being included as dependent variables in mixed linear regression models (ANOVA; or KRUSKAL-WALLIS if non-parametric) with the group as independent factor, time (before, after treatment) and type of treatment.
This study will allow the constitution of a transnosographic atlas of neuro-cognitive deficits in different psychiatric pathologies.
Read the detailed description
- Context : The identification of transnosographic dimensions constituted by cognitive disorders constitutes a particularly promising avenue for classifying psychiatric disorders in a more precise and personalized manner. However, despite interesting preliminary data, there is no exhaustive phenotyping of the different cognitive disorders in large samples where all severe psychiatric disorders are represented. Moreover, the brain mechanisms underlying cognitive disorders remain poorly understood, whereas their identification would allow a better understanding of the pathophysiology of these disorders as well as the identification of potential therapeutic targets.
- Method: Research involving the human being, prospective observational, monocentric (CHU Grenoble Alpes).
- Main objective : to compare cognitive-behavioral performance in patients with different types of severe psychiatric disorders (psychotic disorders, depressive disorders, bipolar disorder, anxiety disorders, autism spectrum disorders and eating disorders) and healthy volunteers to identify specific and shared cognitive alterations between the different severe psychiatric disorders. The primary outcome is the comparison of cognitive-behavioral performance composite scores corresponding to response rates (in %) for each cognitive dimension between the different severe psychiatric disorder groups and the healthy subjects.
- Secondary objective 1: The first secondary objective of PSYCOG is to compare neurophysiological cognitive data in patients with different types of severe psychiatric disorders (psychotic disorders, depressive disorders, bipolar disorder, anxiety disorders, autism spectrum disorders and eating disorders) and healthy volunteers to identify alterations in neurophysiological cognitive mechanisms that are specific to and shared between the different severe psychiatric disorders. Outcome will be the comparison of neurophysiological data from EEG recordings (evoked potentials, spectral dynamics, and brain source) recorded simultaneously with the performance of behavioral tasks for each cognitive dimension between the different severe psychiatric disorder groups and healthy subjects.
- Secondary objective 2: The second secondary objective of PSYCOG is to compare cognitive behavioral performance before and after treatments recommended and routinely prescribed to patients evaluated for a severe psychiatric disorder (psychotropic drug treatment, non-invasive neurostimulation, psychotherapy, psychoeducation, depending on the case) within the different groups of patients with severe psychiatric disorders. Outcome will be the comparison of behavioral data (response rates, reaction times, modeling parameters) from neuropsychological tests before and after treatment (up to + 6 months) in the different groups of patients with severe psychiatric disorders.
- Secondary objective 3: The third secondary objective of PSYCOG is to compare the neurophysiological cognitive data associated with cognitive behavioral tests before and after treatments recommended and routinely practiced in patients evaluated for a severe psychiatric disorder (psychotropic drug treatment, non-invasive neurostimulation, psychotherapy, psychoeducation as the case may be) within the different groups of patients with severe psychiatric disorder. Outcome will be the comparison of neurophysiological data obtained from EEG recordings (evoked potentials, spectral dynamics and brain source) associated with behavioral tests before and after treatment (up to + 6 months) in the different groups of patients with severe psychiatric disorder.
- Inclusion criteria for patients: 18 to 65 years of age, patients suffering from a severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder), patient benefiting from cognitive phenotyping (neuropsychological assessment and possibly EEG) as part of the initial assessment for a severe psychiatric disorder, proven non-opposition to participation in the study, ability to perform cognitive tests: speaking and understanding French easily, presence of an identified support person, absence or presence of a property protection measure such as curatorship or guardianship
- Inclusion criteria for healthy volunteers: between the ages of 18 and 65, proven non-opposition to participating in the study, ability to perform cognitive tests: able to speak and understand French
- Non inclusion criteria: impossible to collect information on exposure (subjects recently arrived in France, foreign language ...), history of coma, epilepsy, head trauma with loss of consciousness over 10 minutes, scalp pathology, subject included in another clinical and/or therapeutic experiment in progress involving the testing of a therapeutic treatment or a drug treatment, opposition to participation in research, inability to perform cognitive tests: non-psychiatric (somatic) condition likely to affect cognitive abilities, sensory or peripheral motor deficits, clinical condition in acute phase (agitation, altered consciousness), protection of property measure such as safeguard of justice, healthy volunteers only: past or current severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder).
- Sample: 360 subjects: 180 patients (30 subjects per group: (6 groups of 30 patients corresponding to severe psychiatric disorders: psychotic disorders, depressive disorders, bipolar disorders, anxiety disorders, autism spectrum disorders, eating disorders) and 180 healthy volunteers
- Procedure: After the patient / healthy volunteer has been informed about the study and has not objected to participating during a routine consultation, the patient / healthy volunteer will be included in the study. Cognitive tests will be collected as part of the patient's usual follow-up according to the pathology.
- Statistics: The different variables corresponding to the judgment criteria will be compared between the groups by being included as dependent variables in mixed linear regression models (ANOVA; or KRUSKAL-WALLIS if non-parametric) with the group as independent factor, time (before, after treatment) and type of treatment.
- Deliverables: constitution of a transnosographic atlas of neuro-cognitive deficits in different psychiatric pathologies.
- Conditions
- Severe Psychiatric Disorders
- Being tested
- Cognitive (behavioural and neurophysiological) screening
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive (behavioural and neurophysiological) screeningDiagnostic test
Cognitive disorders are attested at the behavioral level by the psychologist specialized in neuropsychology who makes the patient take a standardized battery of specific psychometric tests. This assessment thus makes it possible to obtain behavioral data such as reaction time, error rates and modeling parameters.
The electroencephalogram (EEG) consists of collecting the signal of the brain's bioelectrical activity by means of electrodes placed on the scalp. The EEG is used to determine the cerebral functioning underlying cognitive functions by performing it simultaneously with the behavioral tasks of the neuropsychological assessment, thus obtaining a neurophysiological phenotyping of cognitive disorders.
| Study group | Role | What they receive |
|---|---|---|
| Psychotic disorders | Not described Receives: Diagnostic Test: Cognitive (behavioural and neurophysiological) screening | |
| Depressive disorders | Not described Receives: Diagnostic Test: Cognitive (behavioural and neurophysiological) screening | |
| Bipolar disorders | Not described Receives: Diagnostic Test: Cognitive (behavioural and neurophysiological) screening | |
| Anxiety disorders | Not described Receives: Diagnostic Test: Cognitive (behavioural and neurophysiological) screening | |
| Autism spectrum disorders | Not described Receives: Diagnostic Test: Cognitive (behavioural and neurophysiological) screening | |
| Eating disorders | Not described Receives: Diagnostic Test: Cognitive (behavioural and neurophysiological) screening | |
| Healthy volunteers | Not described Receives: Diagnostic Test: Cognitive (behavioural and neurophysiological) screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome
The primary outcome is the comparison of cognitive-behavioral performance composite scores corresponding to response rates (in %) for each cognitive dimension between the different severe psychiatric disorder groups and the healthy subjects.
Measured: At inclusion
Secondary outcomes (3)
Secondary outcome 1
Outcome will be the comparison of neurophysiological data from EEG recordings (composite variable) recorded simultaneously with the performance of behavioral tasks for each cognitive dimension between the different severe psychiatric disorders.
Measured: At inclusion
Secondary outcome 2
Outcome will be the comparison of cognitive-behavioral performance composite score corresponding to response rates (in %) from neuropsychological tests before and after treatment (up to + 6 months) in the different groups of patients with severe psychiatric disorders.
Measured: Through study completion, up to 6 months
Secondary outcome 3
Outcome will be the comparison of neurophysiological data obtained from EEG recordings (composite variable) associated with behavioral tests before and after treatment (up to + 6 months) in the different groups of patients with severe psychiatric disorder.
Measured: Through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Psychiatric DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025566
- Sponsor's protocol ID
- PSYCOG
- Acronym
- PSYCOG
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Phenotyping of Severe Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT05025566
- Acronym / sponsor ID
- PSYCOG / PSYCOG
- Conditions
- Severe Psychiatric Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 27 Aug 2021 (actual)
- 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 identification of transnosographic dimensions constituted by cognitive disorders constitutes a particularly promising avenue for classifying psychiatric disorders in a more precise and personalized manner. However, despite interesting preliminary data, there is no exhaustive phenotyping of the different cognitive disorders in large samples where all severe psychiatric disorders are represented. Moreover, the brain mechanisms underlying cognitive disorders remain poorly understood, whereas their identification would allow a better understanding of the pathophysiology of these disorders as well as the identification of potential therapeutic targets.
Here, the investigators will compare cognitive-behavioral performance in patients with different types of severe psychiatric disorders (psychotic disorders, depressive disorders, bipolar disorder, anxiety disorders, autism spectrum disorders and eating disorders) and healthy volunteers to identify specific and shared cognitive alterations between the different severe psychiatric disorders. In addition, the investigators will compare neurophysiological cognitive data in to identify alterations in neurophysiological cognitive mechanisms that are specific to and shared between the different severe psychiatric disorders.
The investigators will include 180 patients suffering from a severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder) and benefiting from cognitive phenotyping (neuropsychological assessment and possibly EEG) as part of the initial assessment for a severe psychiatric disorder. In parallel, the investigators will include 180 healthy volunteers The different variables corresponding to the judgment criteria will be compared between the groups by being included as dependent variables in mixed linear regression models (ANOVA; or KRUSKAL-WALLIS if non-parametric) with the group as independent factor, time (before, after treatment) and type of treatment.
This study will allow the constitution of a transnosographic atlas of neuro-cognitive deficits in different psychiatric pathologies.
Detailed description
- Context : The identification of transnosographic dimensions constituted by cognitive disorders constitutes a particularly promising avenue for classifying psychiatric disorders in a more precise and personalized manner. However, despite interesting preliminary data, there is no exhaustive phenotyping of the different cognitive disorders in large samples where all severe psychiatric disorders are represented. Moreover, the brain mechanisms underlying cognitive disorders remain poorly understood, whereas their identification would allow a better understanding of the pathophysiology of these disorders as well as the identification of potential therapeutic targets.
- Method: Research involving the human being, prospective observational, monocentric (CHU Grenoble Alpes).
- Main objective : to compare cognitive-behavioral performance in patients with different types of severe psychiatric disorders (psychotic disorders, depressive disorders, bipolar disorder, anxiety disorders, autism spectrum disorders and eating disorders) and healthy volunteers to identify specific and shared cognitive alterations between the different severe psychiatric disorders. The primary outcome is the comparison of cognitive-behavioral performance composite scores corresponding to response rates (in %) for each cognitive dimension between the different severe psychiatric disorder groups and the healthy subjects.
- Secondary objective 1: The first secondary objective of PSYCOG is to compare neurophysiological cognitive data in patients with different types of severe psychiatric disorders (psychotic disorders, depressive disorders, bipolar disorder, anxiety disorders, autism spectrum disorders and eating disorders) and healthy volunteers to identify alterations in neurophysiological cognitive mechanisms that are specific to and shared between the different severe psychiatric disorders. Outcome will be the comparison of neurophysiological data from EEG recordings (evoked potentials, spectral dynamics, and brain source) recorded simultaneously with the performance of behavioral tasks for each cognitive dimension between the different severe psychiatric disorder groups and healthy subjects.
- Secondary objective 2: The second secondary objective of PSYCOG is to compare cognitive behavioral performance before and after treatments recommended and routinely prescribed to patients evaluated for a severe psychiatric disorder (psychotropic drug treatment, non-invasive neurostimulation, psychotherapy, psychoeducation, depending on the case) within the different groups of patients with severe psychiatric disorders. Outcome will be the comparison of behavioral data (response rates, reaction times, modeling parameters) from neuropsychological tests before and after treatment (up to + 6 months) in the different groups of patients with severe psychiatric disorders.
- Secondary objective 3: The third secondary objective of PSYCOG is to compare the neurophysiological cognitive data associated with cognitive behavioral tests before and after treatments recommended and routinely practiced in patients evaluated for a severe psychiatric disorder (psychotropic drug treatment, non-invasive neurostimulation, psychotherapy, psychoeducation as the case may be) within the different groups of patients with severe psychiatric disorder. Outcome will be the comparison of neurophysiological data obtained from EEG recordings (evoked potentials, spectral dynamics and brain source) associated with behavioral tests before and after treatment (up to + 6 months) in the different groups of patients with severe psychiatric disorder.
- Inclusion criteria for patients: 18 to 65 years of age, patients suffering from a severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder), patient benefiting from cognitive phenotyping (neuropsychological assessment and possibly EEG) as part of the initial assessment for a severe psychiatric disorder, proven non-opposition to participation in the study, ability to perform cognitive tests: speaking and understanding French easily, presence of an identified support person, absence or presence of a property protection measure such as curatorship or guardianship
- Inclusion criteria for healthy volunteers: between the ages of 18 and 65, proven non-opposition to participating in the study, ability to perform cognitive tests: able to speak and understand French
- Non inclusion criteria: impossible to collect information on exposure (subjects recently arrived in France, foreign language ...), history of coma, epilepsy, head trauma with loss of consciousness over 10 minutes, scalp pathology, subject included in another clinical and/or therapeutic experiment in progress involving the testing of a therapeutic treatment or a drug treatment, opposition to participation in research, inability to perform cognitive tests: non-psychiatric (somatic) condition likely to affect cognitive abilities, sensory or peripheral motor deficits, clinical condition in acute phase (agitation, altered consciousness), protection of property measure such as safeguard of justice, healthy volunteers only: past or current severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder).
- Sample: 360 subjects: 180 patients (30 subjects per group: (6 groups of 30 patients corresponding to severe psychiatric disorders: psychotic disorders, depressive disorders, bipolar disorders, anxiety disorders, autism spectrum disorders, eating disorders) and 180 healthy volunteers
- Procedure: After the patient / healthy volunteer has been informed about the study and has not objected to participating during a routine consultation, the patient / healthy volunteer will be included in the study. Cognitive tests will be collected as part of the patient's usual follow-up according to the pathology.
- Statistics: The different variables corresponding to the judgment criteria will be compared between the groups by being included as dependent variables in mixed linear regression models (ANOVA; or KRUSKAL-WALLIS if non-parametric) with the group as independent factor, time (before, after treatment) and type of treatment.
- Deliverables: constitution of a transnosographic atlas of neuro-cognitive deficits in different psychiatric pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Psychotic disorders | – | Diagnostic Test: Cognitive (behavioural and neurophysiological) screening |
| Depressive disorders | – | Diagnostic Test: Cognitive (behavioural and neurophysiological) screening |
| Bipolar disorders | – | Diagnostic Test: Cognitive (behavioural and neurophysiological) screening |
| Anxiety disorders | – | Diagnostic Test: Cognitive (behavioural and neurophysiological) screening |
| Autism spectrum disorders | – | Diagnostic Test: Cognitive (behavioural and neurophysiological) screening |
| Eating disorders | – | Diagnostic Test: Cognitive (behavioural and neurophysiological) screening |
| Healthy volunteers | – | Diagnostic Test: Cognitive (behavioural and neurophysiological) screening |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population : Patients with Severe Psychiatric Disorders (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder) Control Population : Healthy volunteers
Key inclusion criteria (6 listed)
- 18 to 65 years of age,
- Suffering from a severe psychiatric disorder (psychotic disorder, mood disorder (depressive and bipolar disorders), anxiety disorder, autism spectrum disorder and eating disorder),
- Benefiting from cognitive phenotyping (neuropsychological assessment and possibly EEG) as part of the initial assessment for a severe psychiatric disorder, proven non-opposition to participation in the study, ability to perform cognitive tests: speaking and understanding French easily, presence of an identified support person, absence or presence of a property protection measure such as curatorship or guardianship
- ages 18 to 65,
- proven non-opposition to participating in the study,
Key exclusion criteria (7 listed)
- impossible to collect information on exposure (subjects recently arrived in France, foreign language ...),
- history of coma, epilepsy, head trauma with loss of consciousness over 10 minutes, scalp pathology,
- subject included in another clinical and/or therapeutic experiment in progress involving the testing of a therapeutic treatment or a drug treatment,
- opposition to participation in research,
- inability to perform cognitive tests: non-psychiatric (somatic) condition likely to affect cognitive abilities, sensory or peripheral motor deficits, clinical condition in acute phase (agitation, altered consciousness),
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 |
|---|---|---|
| Cognitive (behavioural and neurophysiological) screeningCognitive disorders are attested at the behavioral level by the psychologist specialized in neuropsychology who makes the patient take a standardized battery of specific psychometric tests. This assessment thus makes it possible to obtain behavioral data such as reaction time, error rates and modeling parameters. The electroencephalogram (EEG) consists of collecting the signal of the brain's bioelectrical activity by means of electrodes placed on the scalp. The EEG is used to determine the cerebral functioning underlying cognitive functions by performing it simultaneously with the behavioral tasks of the neuropsychological assessment, thus obtaining a neurophysiological phenotyping of cognitive disorders. | Diagnostic test | Anxiety disorders, Autism spectrum disorders, Bipolar disorders, Depressive disorders, Eating disorders, Healthy volunteers, Psychotic disorders |
Primary outcome
Main outcome
Time frame: At inclusion
The primary outcome is the comparison of cognitive-behavioral performance composite scores corresponding to response rates (in %) for each cognitive dimension between the different severe psychiatric disorder groups and the healthy subjects.
3 secondary outcomes
Secondary outcome 1
Time frame: At inclusion
Secondary outcome 2
Time frame: Through study completion, up to 6 months
Secondary outcome 3
Time frame: Through study completion, up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Psychiatric Disorders, run by University Hospital, Grenoble.
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 6 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: opening soon, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clément DONDÉ, MD PhD (+33632415318, cdondecoquelet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main outcome (time frame: At inclusion). 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 27 Aug 2021.