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Mental Disorders clinical trials

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NCT ID: NCT05525962 Recruiting - Child Development Clinical Trials

Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.

EvolASE-PEA
Start date: September 29, 2022
Phase:
Study type: Observational

Assess the prevalence of medico-psychological characteristics at the time of placement (M0), their appearance / disappearance and during the two years following placement (M12 and M24) by age group in children / adolescents in Child Protective Services and placed full-time in the structures of Seine-Maritime and Eure as well as in nursery in Le Havre or Rouen

NCT ID: NCT05511363 Recruiting - Clinical trials for Psychosis Associated With Alzheimer's Disease

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

ADEPT-1
Start date: August 23, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

NCT ID: NCT05510401 Recruiting - Clinical trials for Cognitive Impairment

Evaluation of Safe Use of SECURIDRAP® SELFIA®

SECURIDRAP
Start date: May 18, 2022
Phase: N/A
Study type: Interventional

Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use. Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.

NCT ID: NCT05508789 Recruiting - Alzheimer Disease Clinical Trials

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Start date: October 10, 2022
Phase: Phase 3
Study type: Interventional

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

NCT ID: NCT05501405 Recruiting - Autism Clinical Trials

Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits

FERmarkers
Start date: March 30, 2022
Phase: N/A
Study type: Interventional

Disorders in the recognition of emotional facial expressions are part of the social cognition disorders described in several diseases. They are notably present in a quasi-systematic way in diseases associated with socio-emotional behavior disorders, such as schizophrenia and autism. They are also found in some genetic syndromes with atypical neurodevelopment. In previous studies, the investigators adopted the FPVS-EEG approach to investigate facial emotion discrimination abilities in typical and atypical developing populations. the investigatorshave shown that, in typical adults, the neural response to facial expressions emerges as emotional intensity parametrically increases. A time-domain analysis revealed three components, with the first two increasing linearly with expressive intensity, and the third (beyond 300 ms) showing categorical sensitivity to increasing expressive intensity. The investigators have already successfully extended this approach to the investigation of patients, such as those with 22q11.2 syndrome. The brain response to facial expression was reduced by approximately 36% in these patients, revealing impaired visual coding of emotional facial signals. In this study, response amplitude was associated with positive symptom severity, indicating a potential endophenotype for psychosis risk. Here, the investigators study the implementation of high-level processes and the top-down effect it should have on the response of occipitotemporal regions to identify altered brain markers in schizophrenic patients, but also in other populations with expression recognition deficits (autistic, 22q11.2, in particular). The implementation of compensatory strategies that should result in an increased exploration of the lower part of the face at the oculometric level will also be studied.

NCT ID: NCT05500001 Recruiting - Psychotic Disorders Clinical Trials

Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Background: A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one. Although family support groups exist, few groups offer evidence-based, skills-focused, psychoeducation taught by certified professionals and provided on a public-health level. By equipping families with skills and knowledge, public healthcare harnesses a powerful ally to maintain community stabilization. Aims: The primary study goal is to implement a psychoeducation intervention for family carers supporting young adults with psychosis to reduce family burden and foster community stabilization of service users. Methods: A longitudinal pre-post design will be used to assess the long-term effectiveness of the psychoeducation intervention for family carers supporting a young adult with psychosis on service utilization and functional indexes. Nine expert-reviewed, and family peer-informed psychoeducation modules are administered in 2-hour sessions over 9 weeks to family carers. Conclusion: Presenting the novel approach of an expert-reviewed, peer-informed psychoeducation intervention for family carers, with a focus on knowledge and skill development, the researchers contribute to literature and best practice in patient and family-centered care.

NCT ID: NCT05491486 Recruiting - Clinical trials for Schizophrenia Spectrum and Other Psychotic Disorders

Mindfulness, Empathy and the Oxytocinergic System in Persons With Schizophrenia

OXYGEN
Start date: June 15, 2022
Phase: N/A
Study type: Interventional

Recent studies indicated positive effects of mindfulness-based interventions (MBI) for schizophrenia (SCZ), but also on oxytocin (OXT) levels in healthy persons. It was also shown that response to MBI could be shaped by genetic factors. However, the interplay between mindfulness and empathy and genetic factors with the oxytocinergic system has not yet been examined in SCZ. The aim of the current explorative study is to (1) explore the effect of mindfulness-based group therapy (MBGT) on OXT levels as well as empathy in persons with SCZ; (2) investigate whether polygenic risk scores (PRS) for empathy can predict empathy levels in persons with SCZ; (3) investigate whether PRS for empathy and specific genetic configurations in the oxytocin receptors are associated with MBGT outcomes and OXT levels; 4) examine changes in positive- and negative symptoms, depression, anxiety, social functioning, and mindfulness at a within-group level and between both conditions. A parallel-group, proof-of-concept randomized controlled trial with 30 participants allocated to each trial arm (N = 60) will be conducted. Participants will be randomly assigned to MBGT alongside treatment as usual (MBGT+TAU) or treatment as usual (TAU). For a treatment period of four weeks, participants will receive weekly MBGT sessions. Four weeks after baseline assessments (T0), post-intervention assessments (T1) will take place. As a pilot study, effect sizes will be estimated for within- and between-group effects with corresponding confidence intervals. Outcomes of our proof-of-concept study can provide insight into potential biological mechanisms underlying mindfulness in SCZ, determine a valid biomarker associated with empathy and negative symptoms and pave the way for a personalized treatment approach for individuals with SCZ.

NCT ID: NCT05480826 Recruiting - Clinical trials for Psychiatric Disorder

Familial and Functional Study of Genetic Variants Identified in People With Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder or Resistant Depression

GENI
Start date: March 15, 2023
Phase: N/A
Study type: Interventional

Genetic analyses conducted on patient with psychiatric disorders assessed at the expert centres resulted in the identific action of genetic variants associated with psychiatric disorders (Courtois, 2020). These data require further genetic and functional analyses. The first objective of this study is to investigate the disease-related inheritance of genetic variants in the families of individuals in whom these variants have been identified. The second objective is to explore the functional consequences of disease-associated genetic variants in patients cells and those of their relatives with and without these variants. The present project aims to enrich existing biocollections with DNA from blood or saliva from relatives of patients identified with genetic variants. In addition, we wish to collect hair follicules from patients with identified genetic variants of interest and their family members who wish to participate in the study. These hair samples with SNA will be used to dedifferentiate the isolated cells into induced pluripotent stem cells (IPSCs), and then to differentiate them into cells expressing the gene of interest, such as neurons or astrocytes, or into more complex systems, such as brain organoids.

NCT ID: NCT05457140 Recruiting - Psychosis Clinical Trials

Multiomic Diagnostics in Youth With Psychosis

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

Rady Children's Institute for Genomic Medicine seeks to understand the genomes and immune systems in 15 children and adolescents who are admitted to Rady Children's Hospital Child and Adolescent Psychiatry Service with psychotic symptoms or schizophrenia. Cutting-edge genome and protein sequencing technology will be used to better understand how immunological and genetic assessments may improve our ability to identify the cause of psychosis and impact care. The investigator also hopes to identify new genetic and/or autoimmune causes of psychosis that may inform new treatment for future patients.

NCT ID: NCT05455593 Recruiting - Psychosis Clinical Trials

Effectiveness of the Combination of Water Aerobics and Metacognitive Training

Start date: August 2, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to assess the efficacy of a combined intervention of water aerobics and Metacognitive Training (MCT), compared to each intervention separately, in people with psychosis. One purpose is to analyze the improvement of clinical, cognitive, metacognitive and psychosocial variables, motor coordination and physical health condition. Another purpose is to study the changes in SP1 and SP4 biomarker transcription levels as a function of the intervention received. The hypothesis is that the combined intervention will enhance the benefits of each intervention separately, specifically in symptoms, cognition, metacognition and psychosocial variables.