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Psychosis clinical trials

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NCT ID: NCT06464848 Not yet recruiting - Psychosis Clinical Trials

Narrative Identity and Its Relationship to Subjective Multidimensional Well-being in First Episode Psychosis

PEPsy-Identity
Start date: June 2024
Phase:
Study type: Observational

The transition between adolescence and adulthood (generally defined as ages 18 to 25) is a key developmental window for narrative identity and psychotic disorders. Narrative identity is positively associated with mental health. This study will focus on the acquisition of narrative identity in First Episode Psychosis (FEP) and its impact on multidimensional subjective well-being. The study authors hypothesize that levels of the various components of narrative identity would be lower in the FEP group than in the "chronic" and control groups, and in the "chronic" group versus control group. Given the paucity contradictory nature of the published literature, no hypotheses have been formulated regarding these correlations and predictions. Instead, this study will remain an exploratory analysis in the different samples.

NCT ID: NCT06453174 Active, not recruiting - Psychosis Clinical Trials

CLinical Utility of Early Intervention Including the 5-Step Precision Medicine (5SPM) Method in First-episode Psychosis: The CLUMP Project

CLUMP
Start date: January 1, 2024
Phase:
Study type: Observational

CLUMP is a project of translational research that intends to bridge the gap between what we already know about pharmacogenetics of antipsychotic drugs and what we still do to treat patients with first-episode psychosis (FEP). We aim to improve the adherence to antipsychotic drugs and, therefore, the outcomes of patients with FEP. To achieve this aim, our objectives are to: (1) Introduce a pioneering early intervention model of Personalised Precision Psychiatry, including pharmacogenetics, for patients with FEP; (2) ascertain whether such a model can reduce the elevated discontinuation rates of antipsychotic medications in this group; (3) assess the impact of this model on pragmatic efficacy and functional measures; (4) determine whether this innovation can bring cost benefit; and (5) establish a blueprint for implementing this precision model nationally and internationally. We shall compare all-cause discontinuation rates of the first prescribed antipsychotic medication (primary outcome), discontinuation rates by causes, pragmatic efficacy and tolerability measures, functional outcomes, and healthcare costs between two cohorts of patients with FEP followed for one year. One cohort will be comprised of patients treated before the implementation of the early intervention model of Personalised Precision Psychiatry, and the other of new patients treated under this model. Also, we shall compare pharmacogenetic information, and its implications for clinical management, between these patients and another national cohort of patients with either longer-term psychotic disorders or other mental health problems.

NCT ID: NCT06426134 Not yet recruiting - Psychosis Clinical Trials

Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS

KISSeS
Start date: July 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD). The main questions it aims to answer are: Does a ketone drink improve information processing in patients with SSD/BD? Other questions it aims to answer are: Does a ketone drink improve cognitive functioning in patients with SSD/BD? Does a ketone drink improve metabolism and inflammation in patients with SSD/BD? Research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over'). Participants will: 1. drink a ketone drink and (after a wash-out period) an isocaloric control drink; after each drink: - EEG to determine information-processing parameters (PPI and P300) - cognitive tests - visual analog scale of mood, energy levels, ability to focus - indirect calorimetry to determine use of energy substrate - blood draws 2. for 5 consecutive days: - wear a continuous glucose monitor (CGM) - wear a non-invasive passive sweat biomarker sensor (EnLiSense device) - register a diet and nicotine diary - saliva sampling (max. 4x/day, only on both intervention days)

NCT ID: NCT06408740 Completed - Psychosis Clinical Trials

Physical Activity Level in Psychosis Patients

Start date: September 20, 2023
Phase:
Study type: Observational

The aim of this study was to examine the effect of physical activity level on social participation, functioning and quality of life in patients with psychosis.

NCT ID: NCT06364241 Not yet recruiting - Psychosis Clinical Trials

Focus Groups on Cognitive Function in Psychosis

PRECOGNITION
Start date: June 2024
Phase:
Study type: Observational

Cognitive deficits are commonly observed in people with mental disorders. In psychosis, these impairments are frequently present early in the course of the disorder and have a substantial impact on functional outcomes. This project will gain insight into the cognitive deficits that people with lived experience of psychosis and their carers perceive to be the most troublesome. To achieve this, the investigators will conduct two sets of focus groups. During the first set of focus groups, the investigators will aim to identify the cognitive deficits that individuals with psychosis and their carers consider to be the most impairing. The findings of these focus groups will provide important information about what areas of cognition and functioning should be considered in future analyses of large fully anonymised datasets collected in the past from individuals with psychosis. The focus groups will not form part of those analyses, but will provide input from people with lived experience of psychosis on what problems with thinking skills are the most important for them and that should be considered by further research. The second set of focus groups will enable the investigators to determine the participants' perception of potential risks and benefits associated with the dissemination of findings on cognitive function in psychosis, to ensure this is done in a manner that is sensitive to the wishes and needs of people with lived experience of psychosis. Each participant will be asked to attend one focus group, which will last approximately one hour. Focus groups will take place at the South London and Maudsley (SLaM) Trust or at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, although provision will be made for participants to also participate online.

NCT ID: NCT06328140 Not yet recruiting - Clinical trials for Major Depressive Disorder

Sleep Quality, Cognitive Performance, and Computerized Cognitive Training

Start date: April 15, 2024
Phase:
Study type: Observational

Poor sleep quality is common in neuropsychiatric conditions and some of the problems associated with poor sleep at night may be due to medication side effects or reduced efficacy of certain treatments. Poor sleep quality has been implicated in cognitive impairments, with the sleep quality to cognition association so strong that specialized assessments have been developed to examine the subjective association between poor nighttime sleep and daytime cognitive impairment. Computerized cognitive training (CCT) is a training procedure designed to build cognitive skills, with a goal of improvement of functional outcomes. CCT is also a learning-based approach and previous studies have shown that successful CCT interventions lead to changes in brain circuitry. It is also known, however, that many cases who are treated with CCT fail to make treatment-related gains. Recent studies have suggested that this may be associated with failures to engage in the training procedures, which could be related to sleep related impairments. Increased anticholinergic load can also substantially disrupt the process of training related gains directly. Antihistaminergic effects, common to many antidepressant and antipsychotic medications, can lead to daytime sedation and sleepiness, which both interferes with treatment but also interferes with nighttime sleep as well In previous clinical trials, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and substantial indirect benefits, due to the lack of histamine receptor occupancy, lack of anticholinergic effects, and direct promotion of positive nighttime sleep outcomes. Thus, a broad-spectrum naturalistic comparison of Lurasidone-treated patients with patients treated with other medications is proposed. This would include examining the level of engagement in CCT treatment, measurement of CCT training gains, and relating engagement and training gains with concurrent sleep quality, measured by actigraphy.

NCT ID: NCT06315660 Not yet recruiting - Psychosis Clinical Trials

VR Based Therapy to Treat Anxiety in Dual Diagnosis

Start date: November 2024
Phase: N/A
Study type: Interventional

Dual diagnosis refers to patients with both severe mental illness and substance abuse. Dual diagnosis is therefore a challenging condition to treat, and the group typically represents the most vulnerable individuals in society. Historically, research on dual diagnosis has been underprioritized, and thus, we still do not know enough about how to best assist this vulnerable group. However, new studies indicate that virtual reality programs can reduce anxiety in patients with psychotic disorders. They achieve this by providing access to a virtual therapist and lifelike environments where patients can challenge their thoughts about the dangers of navigating the world. For both psychotic disorders and substance abuse, we know that anxiety often plays a role in the clinical picture. Therefore, anxiety almost always has an impact on dual diagnosis patients, where it is crucial in maintaining substance abuse and functional impairment. Despite this, anxiety is rarely a focus in existing treatment options, as it is too resource-intensive in addition to an already intensive treatment process. This study investigates whether the resource barrier can be overcome and whether hospitalized dual diagnosis patients can experience reduced anxiety, fewer relapses, and better outcomes after discharge when their anxiety is treated through partially automated virtual reality therapy.

NCT ID: NCT06301347 Recruiting - Psychosis Clinical Trials

Learning Through Play Plus for Psychosis

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia.

NCT ID: NCT06224530 Not yet recruiting - Psychosis Clinical Trials

Investigating the Effect of a Single-dose of Levetiracetam on Brain Function, Chemistry and Cognitive Performance in Psychosis Risk

LEVHIPPRO
Start date: February 2024
Phase: N/A
Study type: Interventional

Background Psychosis is a mental health condition that affects around 3 in 100 people in their lifetime. Most treatments for psychosis target a brain chemical called dopamine but they don't work for everyone and don't address many of the symptoms. People with psychosis and people at risk of developing psychosis show differences in a part of the brain called the hippocampus, such as smaller size and increased activity. This hyperactivity may be associated with cognitive difficulties (thinking and memory). The basis of this hippocampal hyperactivity is thought to be a deficit in excitation and inhibition of brain cells. Excitation causes brain cells to send signals more frequently, and inhibition causes cells to send signals less frequently. A balance between these signals is important for the brain, including the hippocampus, to function properly. Approach Levetiracetam is a medication that is widely used to treat epilepsy and which helps balance excitation-inhibition in the brain. We will use brain imaging, using Magnetic Resonance Imaging (MRI), to test if levetiracetam can help reduce hippocampal hyperactivity, alter connectivity and change levels of brain chemicals in people who are at risk of developing psychosis. Participants (18-40 years), identified as at risk of psychosis through the Outreach and Support in South London (OASIS) teams, will attend an initial visit at the Institute of Psychiatry, Psychology & Neuroscience. This will involve questions about experiences and feelings, assessment of thinking and memory, and a blood test. They will then attend two scanning visits at the Centre for Neuroimaging Sciences, during which they will take capsules of either levetiracetam or placebo (in a randomised order) before having a 60 mins MRI scan. The MRI scan will look at blood flow to the hippocampus, resting activity, activity during a cognitive task and levels of brain chemicals. Funded by the Wellcome Trust and conducted by King's College London researchers, the study spans 2-3 months per participant. Impact Our study will provide important evidence about how levetiracetam affects brain function, and how this relates to cognition. This knowledge may lead to innovative approaches for understanding and treating psychosis early.

NCT ID: NCT06221852 Recruiting - Clinical trials for Schizoaffective Disorder

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Start date: March 12, 2024
Phase: N/A
Study type: Interventional

This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.