Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05025566 |
| Other study ID # |
PSYCOG |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
October 1, 2031 |
Study information
| Verified date |
July 2021 |
| Source |
University Hospital, Grenoble |
| Contact |
Clément DONDÉ, MD PhD |
| Phone |
+33632415318 |
| Email |
cdondecoquelet[@]chu-grenoble.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
