Clinical trials

Cocaine is a major psychostimulant used to induce a state of euphoria, improved self-confidence and resistance to fatigue, with suppression of sleep. The progressive use of cocaine leads to a potentially severe addictive process, with sometimes dramatic social repercussions, a major disruption of major physiological functions, such as sleep or nutrition, and risks of psychiatric, neurological or cardiovascular complications. Today, cocaine addiction is considered to be a growing societal problem, due to the fact that the use of this drug is becoming commonplace. There is no validated consensus or protocol for the management of cocaine addiction and no validated pharmacological treatment. The main therapeutic strategy for cocaine addiction is to organize a supervised cessation of use (withdrawal), followed by assistance in maintaining cessation. Withdrawal is a sensitive period that frequently takes place in a hospital setting, as withdrawal symptoms can occur, with major disruption of circadian rhythms, night-time awakenings, daytime sleepiness, high irritability, and sometimes depression. Reducing the desynchronization of nychthemeral cycles during cocaine withdrawal could be a simple strategy to improve the addictive prognosis and comfort of patients. Light therapy is a medical device consisting of the emission of white light enriched with blue light by a lamp or glasses with an intensity sufficient to stimulate the melanopsin cells of the retina and mimic daylight. Overall, light therapy improves sleep quality, mood, cognitive abilities, and decreases fatigue through direct activation of non-visual brain structures. Given the links between cocaine withdrawal and altered sleep or rhythms, there is some evidence to suggest that light therapy used during cocaine withdrawal may improve the prognosis of patients with cocaine addiction.

This study investigates how cocaine use and withdrawal affect sleep and circadian rhythms in individuals undergoing inpatient detoxification. Using wearable sleep monitors, actigraphy, questionnaires, and hormonal biomarkers, it aims to capture both objective and subjective changes in sleep across three key stages: active use, early withdrawal, and late withdrawal. The study is unique in its ability to explore sleep microstructure, the circadian system's role via melatonin and cortisol measurements, and the dynamic relationship between subjective sleep perception and objective sleep data. It also examines whether sleep quality may serve as a predictive marker of long-term withdrawal success.

This study evaluates the efficacy of transcranial direct current stimulation (tDCS) for depression with catatonia in individuals with Down syndrome (DS). 62 patients will be randomized to receive 15 sessions of active or sham tDCS. The primary objective is to measure changes in depressive/catatonic symptoms using the Bush-Francis Catatonia Rating Scale (BFCRS). Secondary objectives include safety, cognitive effects, EEG correlates, and biological markers (cortisol, BDNF, cytokines). The study aims to provide a non-pharmacological therapeutic alternative for this population

Introduction \& Central question: Psychiatric disorders are highly prevalent in the homeless population, however neurodevelopmental disorders are also at risk of leading to homelessness (Churchard et al., 2018; Casey et al., 2020). Research on this topic is poor in France. This research aims to study the prevalence in France of 3 neurodevelopmental disorders (NDDs) in a homeless population (Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder and Intellectual Developmental Disorder). Methods / approach: A 2 phase approach will be used including a screening phase and a diagnosis phase. This research is a pilot study that will include 150 homeless people, over 2 years. The assessment involves combining the results from standardised self-report tools, direct observation and informant-report, thus guaranteeing an objective and thorough diagnosis. This approach gives a better picture of actual behaviour but also a better understanding of the person's development. OUTCOME: This study will give insight on how to better understand the profile of the homeless population in France, and the prevalence of autism in this population. It will also bring valuable knowledge on how autism and other NDDs can impact one's path in life and lead to homelessness. The results can help develop targeted cares and measures for homeless people with NDDs.

This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors.

A violent death is defined by its brutality, unexpectedness and is secondary to an external cause (suicide, homicide, accident). Bereavement following a violent death constitutes a particular clinical situation, at risk of complications. Research on bereavement after a violent death shows higher risks of psychiatric and somatic complications than in bereavement by non-violent death. These complications, sometimes comorbid, take the form of depressive episodes, post-traumatic stress disorders, suicidal behavior and prolonged grief disorders after 12 months, precociously mediated by ruminations. Processes responsible for this increased risk of complications are poorly documented. Current literature relates mainly to socio-demographic and epidemiological factors which, alone, do not explain this difference in risks. Further research is needed exploring other kinds of data and processes. To our knowledge, there is no description of early neurocognitive functioning in people bereaved after violent death. This study aims at exploring early neurocognitive processes which can lead to complications in people bereaved by violent death.

Training of mental health service teams in the orientation of care towards recovery through a 3-day training course: REFOCUS. This training aims to orient care towards recovery. Following this training, evaluation of the effectiveness of the implementation of REFOCUS training in mental health services.

Reality-monitoring characterizes the ability to determine whether information was perceived in the environment or only imagined . Impaired reality-monitoring abilities have been associated with hallucinations in patients with schizophrenia and patients with Parkinson's disease. The investigators hypothesize a link between dopaminergic (DA) transmission and reality-monitoring.

In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. For single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. For caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. Therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care. Currently, the organization of the French care system does not allow these recommendations to be met. In order to increase the use of psychoeducation in France, early interventions for caregivers must be offered systematically. The effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in France.

Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols. The aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.

To ensure unified sensory perception, the brain must link information from different senses across time and space. This unification of perception often referred to as a perceptual "binding constraint" is a prerequisite for any organized perception. Patients with schizophrenia exhibit deficits in the spatiotemporal binding of sensory information . Electroencephalography (EEG) studies highlight the role of delta-theta oscillatory dynamics (2-8 Hz) in neuronal entrainment processes underlying spatiotemporal binding, which enables the formation of a coherent and organized perceptual representation . These same dynamics are disrupted in schizophrenia . In tasks assessing perceptual binding, such alterations manifest as widened temporal binding windows, reflecting impaired temporal structuring of visual events. Physiologically, these disruptions may stem from impaired feedback mechanisms within the cortico-cerebello-thalamo-cortical (CCTC) loop. Schizophrenia patients also exhibit functional and structural deficits in the pulvinar and frontal cortex, key nodes of the CCTC loop . Recent technical advances in transcranial neurostimulation have reinforced its potential as a therapeutic tool. High-definition transcranial alternating current stimulation (HD-tACS) now enables individualized modulation of pre-identified neural networks , including targeted interventions for schizophrenia . Based on a personalized stimulation protocol, this research project proposes precision HD-tACS therapy, tailored for each patient according to their delta-theta peak frequency measured via EEG and the optimal functional stimulation site identified with functional MRI (fMRI). Stimulation will be applied functionally, i.e., while the patient performs a cognitive task. Structural connectivity alterations have been observed in fronto-thalamic, thalamo-cingulate, and cortico-cerebellar pathways in schizophrenia, potentially underpinning temporal and spatial binding deficits. Assessing the integrity of the CCTC loop with diffusion tensor imaging (DTI) will allow quantification of fiber coherence and white matter density connecting cortical and subcortical regions within this network.To evaluate both baseline perceptual deficits and the potential improvements induced by stimulation, a control group of healthy participants will be included.

The aim of this study is to assess the impact of implementing a specific family program coordinated by APRNs, covering the 5 levels of the family care pyramid through a consultation, an individual psychoeducation program and a group psychoeducation program, on improving caregiver burden and thus contributing to the recovery of users suffering from FEP. Detailed Description: Psychotic disorders are among the most disabling chronic pathologies in psychiatry. These disorders modify the individual's perceptions, thoughts, moods, behaviours and day-to-day functioning (Implementing interventions as early as possible in the first psychotic episode (FEP) would be likely to decrease the severity and consequences of the illness and improve prospects for recovery. Evidence supports the establishment of multidisciplinary teams to detect early and treat early those experiencing FEP and those at increased risk of psychosis. Recommended interventions include cognitive-behavioral therapies, family interventions, employment and educational support, and above all, at the heart of the system, case management. These specialized teams need to be multidisciplinary, bringing together psychiatrists, psychologists and social workers in addition to case managers. More recently in France, Advanced practice nurse (APRN) have joined these teams. But getting young people to accept both disorders and care is a difficult necessity, and remains a major challenge. Poor compliance with treatment is said to be one of the primary causes of relapse after FEP. Factors that increase the risk of relapse include initially more severe symptoms, persistent substance abuse, poor adherence to treatment and inadequate support from family and friends. Nowadays, support from a close caregiver for a person living with a psychic disorder is recognized as a very favorable factor for long-term prognosis. But the occurrence of a FEP often has the effect of a tidal wave for loved ones, who present high levels of psychological distress and feelings of burden. Unfortunately, it is still difficult for families to gain access to family caregiver support services, which are still insufficiently available and often unknown to them. A number of barriers stand in the way of systematically proposing family interventions, such as health professionals' lack of awareness of the effectiveness of interventions aimed at family carers, their difficulty in establishing a double therapeutic alliance with the young person and his or her family, or the misperception that family interventions are in contradiction with professional secrecy. The pyramid of family care in early intervention presents the family support that should be available to families of young people with FEP. The levels of intervention are designed to meet the support needs of family caregivers and can be used flexibly depending on specific needs or the phase of the psychotic episode. Also, APRNs could contribute to the success of these caregiver support programs thanks to their skills in prevention, assessment and coordination of complex pathways. This study therefore aims to determine the extent to which a specific program coordinated by APRNs can influence the burden of a family caregiver of a young person suffering from FEP.

This study aims to explore whether the observation of complex visual objects can help improve social cognition in people living with psychotic disorders. Social cognition refers to the ability to understand what others think, feel, or intend, and plays a key role in social relationships and daily interactions. Main questions this study aims to answer: * Does dyadic exposure to complex visual objects improve mental state attribution, as measured by the Faux Pas Test? * Does the intervention enhance related domains of social cognition, including implicit intention inference (Hinting Task), interpretation of complex interactions (Movie for the Assessment of Social Cognition, MASC), and reduction of hostile attribution biases (Ambiguous Intentions Hostility Questionnaire, AIHQ)? * Are improvements maintained after one month, and do patients who receive the intervention later (waitlist group) show the same benefits once exposed?

The goal of this study is to validate the virtual version of the Multiple Errands Test (V-MET) as a tool for assessing executive functions in patients with alcohol use disorder (AUD). More specifically, the project aims to: 1. evaluate if the performance in the virtual version of the test is related to the performance in the original test in patients with AUD. 2. establish whether the virtual version of the test is sensitive enough to detect patients with or without an executive function deficit. All participants will perform the original version (in a real-life supermarket) and the virtual version of the test (in a virtual reality environment). Performance in the two versions of the test will be compared. Participants will also complete a battery of neuropsychological tests and questionnaires.

Since 2014, suicide prevention has been a national priority and is one of the 3 priority areas of the mental health plan's roadmap . Hospitalization offers a crucial opportunity for life-preserving intervention . Brief health interventions and contacts are reputed to be easy to implement, effective and inexpensive . The Hope Box is a practical emotional management tool that aims to encourage the expression of reasons for living by materializing them in a customizable box, filled with objects, photos, writings and memories in order to find comfort and hope . Peer support use their experiential knowledge of disorders and recovery to accompany people and help humanize care . They can play a decisive role in suicide prevention . In contrast to an approach focusing only on risk factors, peer support and the Hope Box are both focus on protective factors, the strengths of the people concerned and hope. The primary objective of this study is to evaluate the feasibility of the HOPAIR intervention (peer-support and Hope Box, completed by a reminder postcard) with suicidal people hospitalized in psychiatric crisis units. Its secondary objective is to assess the potential effectiveness on intensity of hopelessness, sense of self-efficacy, reasons for living, perceived social support and suicidal recurrence at 3 months. This is a mixed-methods study involving 40 patients and 2 peer support in two crisis hospitalization units.

Emotions play a crucial part in the quality of life, interpersonal relationships and mental health in general. In adults presenting with intellectual developmental disorder (IDD), emotional abilities may be hindered, thus leading to more challenging behaviors. A better understanding of emotional processes of adults with IDD may help improve the efficiency of behavioral interventions and better improve their quality of life. The primary goal of this study is to better characterize the abilities and weaknesses of adults with IDD concerning their emotional processes, in comparison to a healthy population. The secondary goals are : * to determine if these difficulties are underlined by oculomotor and attention (auditory and visual) processes * to determine if behavioral difficulties, as reported by the families of adults with IDD, are underlined by specific difficulties in facial emotion recognition, emotion identification in context and/or identification of vocal emotions.

Borderline Personality Disorder (BPD) involves altered social cognition, notably dysfunctional processing of cues signaling potential social exclusion and heightened social pain. This study uses EEG during a controlled Cyberball task to test whether BPD patients show a functionally altered social-pain network, particularly increased theta activity, when experiencing induced social exclusion.

This study investigates the temporal dynamics of perception and attention in children with Autism Spectrum Disorder (ASD), focusing on two key phenomena: the Temporal Integration Window (TIW) and the attentional blink. Using eye-tracking, 3- and 5-year-old children with ASD (prototypical or not) will be compared to age-matched neurotypical peers. The investigators hypothesize that children with ASD exhibit shorter TIWs and attentional blinks, reflecting faster perceptual sampling and attentional processing. These characteristics may contribute to sensory hypersensitivity and difficulties in complex, unpredictable environments such as social situations. The protocol includes two experimental tasks.

The main objective of this study is to develop a models of sequential decision-making, learning and motivation that includes emotions as driving forces of adaptive behaviour. Using functional magnetic resonance imaging (fMRI), the investigators will test the hypotheses that distinct parts of the prefrontal cortex play specific roles in naturalistic decision-making. The main hypothesis is that distinct regions of the prefrontal cortex will be differentially involved in learning, motivation, and decision-making in naturalistic tasks. More specifically, the investigators hypothesise that by using a novel set of tasks they have designed in combination with fMRI, they can construct a neurocognitive model that explains how humans make adaptive decisions in dynamic and temporally extended reward environments. A key region that the investigators believe will play a role in representing the internal and external parameters necessary for adaptive behaviours in the tasks is the anterior cingulate cortex. Depending on the task requirements, this region will further interact with other distinct prefrontal regions such as the frontal pole or dorsolateral prefrontal cortex. Secondary hypotheses will also be investigated, specific to each specific task. All data will be collected during a single visit lasting approximately 3.5 hours for each participant. Participants will perform a cognitive task inside the MRI scanner. Each participant will perform only one of the three possible cognitive conditions/tasks (Treasure Hunt, Fastest Queue, or Farm Game). Each task is presented in the form of a video game played on a computer. Participants play a character who makes repeated choices. Participants are asked to try to collect as many points as possible within a limited time frame (Farm Game) or with limited trials (Fastest Queue and Treasure Hunt).

Adults with intellectual disabilities have great difficulty in adapting to social situations and relationships. Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved. Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are adults with intellectual disabilities manner in their daily functioning

the investigators will measure source-monitoring ability in patients with several neuropsychiatric condition and in healthy controls appaired in age, sex and educational level. Source-monitoring will be measured thanks to internal- and reality-monitoring informatic tasks.The investigators hypothesized patients with fronto-temporal abnormalities would show more marked deficits than patients with only frontal abnormalities.

In France, the "Consultations Jeunes Consommateurs" (CJC) are the services specialized in the reception of young people for addiction problems. There are more than 500 CJCs throughout France. Depending on the situation, the CJC develops an early intervention strategy aimed either at reducing the risk of developing an addiction or at accelerating entry into appropriate care. The CJCs also meet with family members or professionals who may also independently request help or advice. Set up by the State since 2004, the action of the CJCs has never been formally evaluated. Only descriptive studies, carried out by the French Observatory of Drugs and Drug Addiction (OFDT), have made it possible to better understand the profile of people who consult CJCs. However, no longitudinal study has yet been carried out to understand the factors associated with the overall evolution of users consulting CJCs, nor with the level of satisfaction of users and those around them. Such objectives are complex, due to the diversity of situations encountered in CJCs and the heterogeneity of the CJCs themselves.

The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome

The present study aims to characterize and modulate motor imagery abilities in individuals with aphantasia. The investigators will characterize the neurophysiological and physiological underpinnings of mental imagery abilities in participants with aphantasia by investigating several indices of motor imagery abilities and comparing them to participants with typical mental imagery abilities. The investigators will investigate whether non-invasive brain stimulation applied to the primary motor cortex improves mental imagery abilities in participants with aphantasia.

Investigators will measure the variation of blood Metabolome through 1H NMR at several time points during the course of electroconvulsivetherapy in patients with a major depressive episode. Patients with a major depressive disorder or a bipolar disorder and a current major depressive episode will be included in this study. Investigators hypothesized that Metabolome could be a source to predict response during ECT and to help understanding underlying biological mechanisms.