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Psychotic Disorders clinical trials

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NCT ID: NCT05834309 Recruiting - Metabolic Syndrome Clinical Trials

Exercise Effects on Health Status in Patients With Severe Mental Illness

SMI01
Start date: December 5, 2022
Phase: N/A
Study type: Interventional

People with severe mental disorders have a mortality rate 2 to 3 times higher than that of the general population, largely due to the presence of comorbidities, with a predominance of cardiovascular disease. This population has a higher risk of developing metabolic syndrome compared to the healthy population. Several factors are involved. The usual pharmacological treatment in people with severe mental disorder is a risk factor for the development of metabolic syndrome and deterioration of physical condition. This is generally compounded by poor health care, high-calorie diets, a sedentary lifestyle, difficulties in coping with life situations that generate emotional states (anxiety and/or depression) that result in unhealthy lifestyle habits related to food, activity, interpersonal relationships, sleep, consumption habits (tobacco, alcohol and drugs) and other environmental factors. Physical exercise has been proposed as one of the most effective treatments to reverse the negative consequences of low levels of physical activity in this population. However, the mechanism of action of exercise on health status and the optimal "dose" and intensity of exercise to achieve the greatest number of benefits with respect to cardiometabolic health in patients with severe mental disorder are unknown.The study will be carried out at the Mental Health Rehabilitation Unit of Navarra, a center under the Mental Health Management of Osasunbidea, where people between 18 and 65 years of age with a diagnosis of severe mental illness in a situation of clinical stability receive treatment.The sample will be composed of 100 participants from consecutive admissions to the Rehabilitation Unit. The subjects will be randomized into 2 groups; a control group that will receive the usual specialized care and an intervention group, which in addition to receiving the usual rehabilitation treatment, will undergo a 6-week multicomponent physical exercise program performed 2 days per week. The effects of exercise on the inflammatory profile, metabolic parameters, physical condition, cognitive function, vascular function, muscle strength, health-related quality of life, lifestyle habits (diet, activation, sleep, substance use) and mood will be evaluated.

NCT ID: NCT05827900 Recruiting - Clinical trials for Clinical High Risk for Psychosis

Metacognitive Training in Ultra-high Risk

Start date: October 21, 2023
Phase: N/A
Study type: Interventional

The aim of this pilot study is to examine whether metacognitive training can improve symptoms, wellbeing and functioning in individuals with attenuated psychotic symptoms. Metacognitive group training is an intervention designed to raise awareness on and change cognitive biases that may foster the development of psychotic symptoms such as delusions. It has been shown to be helpful in people with manifest psychosis. The main goal is to assess whether this training is prone to reducing symptoms in individuals at risk for psychosis. Participants will be randomized either to treatment as usual or to treatment as usual plus metacognitive training. Follow-ups will be performed over the period of one year.

NCT ID: NCT05824728 Recruiting - Clinical trials for Parkinson Disease Psychosis

Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis

AGB101 PDP
Start date: September 28, 2023
Phase: Phase 2
Study type: Interventional

This clinical trial will test whether AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) can improve symptoms of psychosis in Parkinson's disease. Participants will be asked to complete up to 5 in-person study visits over approximately 20 weeks. Participants will receive both AGB101 and a placebo to take once a day for 6 weeks, with a 4-week washout in between. Participation will also involve physical/neurological exams, questionnaires, paper and pencil tests, providing blood and urine samples, and completing two MRI exams.

NCT ID: NCT05824117 Recruiting - Schizophrenia Clinical Trials

Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education.

SEEearly
Start date: October 18, 2022
Phase: N/A
Study type: Interventional

Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. The investigators compare treatment as usual (TAU) in an outpatient psychiatric setting to TAU plus SEE.

NCT ID: NCT05815225 Recruiting - Psychosis Clinical Trials

Neuroinflammation Markers in Subjects With Psychotic Symptoms

NEUROINPS17
Start date: November 1, 2017
Phase:
Study type: Observational

The main objective of the study is to measure the plasma and intracellular levels of several neuroinflammation markers (including cytokines and chemokines) and the endocannabinoid system in subjects presenting psychotic symptoms, initially recruited in a Mental Health Hospitalization Unit, and in different stages of their disease. To this end, we will evaluate and clinically characterize a cohort of patients who present active psychotic symptoms at the time of recruitment, and comparing it with a control group with similar sociodemographic characteristics. We will also compare our sample with a smaller sample previously recruited from patients with substance use and psychotic symptoms. Within our cohort of patients with psychotic symptomatology we will distinguish in turn affective psychoses from non-affective psychoses, on the one hand; and induced and non-induced psychosis by drug consumption, on the other. We will also classify patients based on whether they are experiencing the first episode of their illness or a relapse. This is an observational, longitudinal and prospective study. 3 blood draws will be performed from the subjects included in the study: the first, in the first 48 hours of hospital admission; the second, in the 48 hours prior to discharge; and the third, 6 months after discharge. The rater team will be composed of senior psychiatrists and training psychiatrists. The sample will be composed of subjects with psychotic symptoms who come from the Mental Health Clinical Management Unit of the Regional University Hospital of Malaga. Each patient enrolled in this study will undergo a clinical evaluation (psychiatric diagnostic interview and psychometric scales). From the plasma and white blood cells of the blood sample, the biochemical levels of the inflammatory mediators will be determined. Demographic, clinical, and biochemical data will be assessed and analysed using statistical programmes.

NCT ID: NCT05814913 Recruiting - Psychosis Clinical Trials

Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting

CaCBT+CulFI
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Primary Aims: To determine the clinical efficacy of Culturally adapted Cognitive Behavioral Therapy (CaCBT) and Culturally adapted Family Intervention (CulFI) compared to Treatment As Usual (TAU) on reducing overall symptoms of psychosis in patients with First Episode Psychosis (FEP) in Pakistan. Secondary Aims: 1. To determine the efficacy of CaCBT and CulFI compared to TAU on positive and negative symptoms of psychosis, general psychopathology, depressive symptoms, quality of life, general functioning, and insight in patients with FEP in Pakistan. 2. To determine the efficacy of CaCBT and CulFI compared to TAU on improving carer experience, carer wellbeing, carer illness attitudes and symptoms of depression and anxiety in family and carers of patients with FEP in Pakistan. 3. To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan. 4. To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings 5. To explore delivery and reach of each intervention, tolerability of intervention components, acceptability of interventions, understanding mechanism of change and developing an understanding of barriers and facilitators to future adoption using process evaluation. Study design and setting: This will be a multi-centre, assessor masked, individual, three-arm randomised controlled trial (RCT). Sample Size: The study aims to recruit a total of N=390 participants with FEP

NCT ID: NCT05813457 Recruiting - Psychotic Episode Clinical Trials

Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis

PRESTO
Start date: June 6, 2023
Phase: N/A
Study type: Interventional

The First-Episode Psychosis (FPE) is a severe disorder that can include delusions, cognitive disorders and suicidal behavior. In the majority of cases (more than 80%) it evolves into schizophrenia. Numerous studies show that the rapidity of the initial management of FPE would reduce the risk of negative evolution and would have a decisive impact on the short and long term prognosis. The rapidity of this management can be measured by the duration of untreated psychosis, or DUP (Duration of Untreated Psychosis), the time interval between the appearance of the first frank psychotic symptoms and the initiation of adequate psychiatric care. The objective of this study is to show the impact of an intervention facilitating access to specialized care for PEP on the reduction of DUP. This intervention consists of an early identification program for FPE, the PRESTO program, specifically targeting 3 determining steps in the reduction of DUP: - Informing the general population about psychotic disorders - Knowledge of front line actors (APL: general practitioners, school and university medicine, teenager's house, associative networks educators, emergency services, firefighters, etc.) about FPE and its management - Articulation between APL and specialized psychiatric care

NCT ID: NCT05813080 Recruiting - Psychotic Disorders Clinical Trials

Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders

CARE
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis.

NCT ID: NCT05805397 Recruiting - Schizophrenia Clinical Trials

Effectiveness of Motivation Skills Training (MST)

MST
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This study will take place at four outpatient clinics serving adults with serious mental illness. Informed consent will be obtained from N=80 individuals with a Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 diagnosis of schizophrenia or schizoaffective disorder meeting inclusion/exclusion criteria to participate in a randomized controlled trial comparing Motivation Skills Training (MST) to a Healthy Behaviors Control (HBC) group. Eligible participants will receive a baseline assessment including sociodemographic and psychosocial assessments, measures of motivation, goal attainment, and quality of life, as well as measures of executive skills, community functioning, and psychiatric symptoms severity. Both MST and HBC will be implemented as once weekly group therapies. The treatment phase is approximately 12-14 weeks. MST will focus on motivation knowledge and self-regulation skills while HBC will focus on physical health and health-related skills.

NCT ID: NCT05769933 Recruiting - Healthy Clinical Trials

Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging

Start date: September 21, 2022
Phase:
Study type: Observational

The human brain presents outstanding challenges to science and medicine. Brain function and structure span broad spatial scales (from single neurons to brain-wide networks) as well as temporal scales (from milliseconds to years). Currently, none of the tools available for studying the brain can fully capture its structure and function across these diverse scales - "the neuroimaging puzzle". This poses crucial limitations to understanding how the brain works, and how it is affected by numerous diseases. The central goal of this project is to expand currently available tools for non-invasive human brain imaging, to bridge critical gaps in the neuroimaging puzzle. New methodologies will be developed, focused on ultra-high field magnetic resonance imaging (UHF MRI) and its combination with electroencephalography (EEG). New contrast mechanisms and technological advances enabled by UHF MRI and EEG will be explored to allow unprecedented views into the microstructure of brain regions like the thalamus, and to capture the activity of large-scale neuronal networks in the brain with high sensitivity, temporal and spatial specificity. These advances will be directly applied to address open questions in the diagnosis and treatment of essential tremor, and psychosis. In general, improved brain imaging techniques are critical for a deeper understanding of how the brain works, and to detect and characterize diseases more effectively, thereby improving clinical management and leading to a healthier population. The non-invasive characterization and treatment of neurodegenerative diseases like tremor is particularly relevant to aging modern societies.