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Schizophrenia clinical trials

View clinical trials related to Schizophrenia.

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NCT ID: NCT04618250 Completed - Schizophrenia Clinical Trials

Improving Physical Health in Patients With Psychiatric Disorders in General Practice (SOFIA)

SOFIA
Start date: November 6, 2020
Phase: N/A
Study type: Interventional

People with a severe mental illness (SMI) have an increased risk for premature mortality, predominantly due somatic health conditions. Evidence indicates that prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (SOFIA model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The primary outcomes are description of study feasibility (recruitment and retention) and acceptability. The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period. If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.

NCT ID: NCT04612777 Completed - Bipolar Disorder Clinical Trials

A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses

ODR
Start date: June 15, 2014
Phase: N/A
Study type: Interventional

Insufficient community-based support after inpatient discharge for persons with serious mental illnesses (SMI) may lead to re-hospitalization, excessive criminal justice involvement, homelessness, and an inability to embrace recovery. In fact, many of these especially vulnerable persons find themselves in a cycle of repeated hospital stays, arrests, and even homelessness, with little support for real recovery. Public mental health systems are struggling to address these problems. Evidence-based, comparatively inexpensive, time-limited community support models are needed to reduce institutional recidivism and facilitate recovery. The Georgia chapter of the National Alliance on Mental Illness (NAMI-GA) developed Opening Doors to Recovery (ODR), and we have collected extensive preliminary data on it. ODR is now being tested in a randomized controlled trial (RCT) taking place in southeast Georgia where ODR was first developed. The primary goals of ODR are to prevent institutional recidivism (i.e., going back into the hospital) and to promote recovery among persons with SMI like schizophrenia and bipolar disorder. The ODR intervention is comprised of several components that work together to address barriers to successful integration into the community among individuals with SMI and repeated inpatient hospitalizations. A team of 3 specially trained "Community Navigation Specialists" (CNSs, also called Navigators) provides intensive, mobile, community support to persons with SMI with a defined history of inpatient recidivism (i.e., repeated hospital stays). We are carrying out a fully powered trial of ODR in a 7-county catchment area in southeast Georgia, which is an ideal real-world location to carry out the study. During the 5-year study period, we will randomize 240 persons with SMI and a history of ≥2 inpatient stays in the past 12 months to ODR (n=120, followed for 12 months, with a maximum CNS caseload of 40) versus community care in traditional intensive case management or case management (ICM/CM, n=120). Assessments are conducted at baseline (just before hospital discharge), and at 4, 8, 12, and 18 months.

NCT ID: NCT04611737 Completed - Schizophrenia Clinical Trials

Self-Determination Theory and Motivational Interviewing

Start date: November 3, 2020
Phase: N/A
Study type: Interventional

Self-Determination Theory and motivational interviewing would be integrated to enhance the efficacy of diabetic self-management for patients with schizophrenia and Type 2 Diabetes.

NCT ID: NCT04605393 Completed - Schizophrenia Clinical Trials

Does Cannabidiol Attenuate the Acute Effects of ∆9-tetrahydrocannabinol Intoxication in Individuals Diagnosed With Schizophrenia? A Double-blind, Randomised, Placebo-controlled Experimental Study

INTEGRATE
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

This study will recruit schizophrenia patients who use cannabis recreationally. Each participant will attend the laboratory on three occasions: an initial visit to check that they are safe to join the study and two days of testing. Participants will be administered, in a randomized order, a pre-treatment with either CBD (1000mg) orally or a matching placebo. On both experiments, participants will then inhale cannabis containing THC. The THC administration will follow a standardised inhalation procedure using a medical-grade vaporizer device. Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences. The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.

NCT ID: NCT04602741 Completed - Schizophrenia Clinical Trials

Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement

Start date: January 4, 2021
Phase: N/A
Study type: Interventional

The effective treatment of schizophrenia is very challenging due to a number of factors. These include issues such as poor engagement with treatment plans and care providers, limited contacts with providers due to under-resourced health services, and the challenges inherent to schizophrenia symptoms. The outcomes of these problems include frequent, lengthy, and costly hospital readmissions, low quality of life, high levels of distress, and difficulties engaging in valued community roles. Digital Health technologies are a promising model to help address these problems. They are a low cost and accessible form of support and have not been substantively developed or studied for people with schizophrenia spectrum illnesses. In this study, the feasibility of one such technology that is in development will be tested: App4Independence (A4i). A4i provides customized coping prompts, peer-peer networking, and a portal that facilitates better provider engagement. This research will provide critical information in the development of this new technology to address a key problem in the field - how to enhance care in a resource-limited context where provider-patient contacts are brief, infrequent, and rely on in the moment recall and self-advocacy by patients. These findings will lay the groundwork for a larger program of research and software development that will (i) validate the technology across multiple sites and, (ii) catalyze engagement with healthcare systems and caregiver networks to scale-out access to this promising resource.

NCT ID: NCT04598906 Completed - Depression Clinical Trials

Ecologically Valid Virtual Tasks vs Paper-pencil Methods in Cognitive Rehabilitation in Patients With Schizophrenia and Depression

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Schizophrenia is heterogeneous and often disabling a disease that affects 1% of the population. Current psychopharmacological treatment significantly eliminates the presence of positive symptoms (especially delusions and hallucinations) and partly also negative symptoms (social withdrawal or abulia). In contrast, the cognitive deficits associated both with schizophrenia and depression are only limitedly influenced by pharmacological treatment.The cognitive impairment represents an important part of schizophrenia symptomatology and it has a severe negative impact on patients' quality of life. In depression is the impairment milder but still significantly contributes to patients' daily functioning. The profound deficit was repeatedly documented in the area of declarative and working memory. In this study, we study the effectiveness of virtual environment rehabilitation program focused on declarative memory, working memory and attention in comparison to standard paper-pencil rehabilitation led by an occupational therapist.

NCT ID: NCT04590300 Completed - Schizophrenia Clinical Trials

Impact of Cognitive & Metacognitive Performance on Knowledge Learning When Conducting Therapeutic Education Programs

MetaCOGNITION
Start date: October 6, 2020
Phase: N/A
Study type: Interventional

People with schizophrenia and bipolar disorder display alterations in cognition and metacognition. These alterations may have an impact on learning during therapeutic education programs.

NCT ID: NCT04588129 Completed - Schizophrenia Clinical Trials

Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers

Start date: January 5, 2021
Phase: Phase 1
Study type: Interventional

This is an open label study in 4 cohort of 4 healthy volunteers each designed to evaluate the dopamine receptor occupancy of LB-102 at various doses and timepoints.

NCT ID: NCT04578314 Completed - Schizophrenia Clinical Trials

RELATE - Efficacy and Feasibility of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations

RELATE
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show some promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH through the use of experiential role-plays. A single centre pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but independent multicentre studies are required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial set up to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities.

NCT ID: NCT04572685 Completed - Clinical trials for Schizophrenia Patients

Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients

Start date: January 22, 2020
Phase: Phase 1
Study type: Interventional

The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single IM injection of 156 mg dosage level.