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Schizophrenia clinical trials

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NCT ID: NCT02879604 Completed - Schizophrenia Clinical Trials

Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia

Grecco
Start date: March 5, 2018
Phase: N/A
Study type: Interventional

Significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years, alternative non-pharmacological therapeutics have been developed in schizophrenia. These techniques called cognitive remediation specifically target cognitive deficits. The first cognitive remediation available for patients was designed to stimulate new learning, or relearning, of cognitive tasks, and thus to improve certain deficient domains. These procedures were efficient in improving cognition as measured by neurocognitive tests but their impact on functioning and daily life was weak. In a second time, compensatory remediation has been developed. Compensatory approaches seek to make improvements in the patient's functioning by avoiding areas of impairment and recruiting other intact cognitive domains or by creating a supportive external environment. In recent meta-analysis compensatory remediation has larger effect-size than classical cognitive remediation, with an impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of California) developed and tested a group-based, manualized, compensatory cognitive training intervention. Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily transposable in community care. Our team translated this method into French. The investigators planned a cost -utility study between CCT and treatment as usual in schizophrenia patients with less than 10 years of evolution.

NCT ID: NCT02879591 Recruiting - Schizophrenia Clinical Trials

Enhancing Social Interaction With an AlterEgo Artificial Agent

ALTEREGO
Start date: April 2014
Phase: N/A
Study type: Interventional

The objective of AlterEgo is the creation of an interactive cognitive architecture, implementable in various artificial agents, allowing a continuous interaction with patients suffering from social disorders, by virtue of changes in behavioural (robot-based) as well as morphological (avatar-based) properties of that agent. The project includes research in fundamental and clinical neurosciences, interaction modeling, development of new computer-vision techniques and human-robot interfaces, as well as evaluation of the scenarios with patients before, during, and after training sessions. At the end of the project, the investigators will produce a new avatar-based clinical method able to enhance social interaction of patients. The first challenge of this project is to create an avatar alter ego of a patient. Based on recent work in social robotics and neurosciences, the investigators hypothesize that if patients face artificial agents morphologically and behaviourally similar to them, they will increase their social interaction. The second challenge is to transform the morphology and the behaviour of the similar artificial agent into that of a healthy and different agent. The investigators assume that the smooth and continuous behavioural shift from similar/unhealthy to complementary/healthy social behaviour will lead to a better social rehabilitation. AlterEgo opens the door to a new generation of social artificial agents in service robotics. AlterEgo is an interdisciplinary project at the interaction of Social Motor Neurosciences (UM1), Robotics (EPFL), Complex Systems Dynamics (UOB), Computer Vision (DFKI), and Psychiatry (CHU). This project includes a set of experiments that started in april 2014 and will terminate in september 2016 before undergoing a randomised clinical research.

NCT ID: NCT02878408 Recruiting - Schizophrenia Clinical Trials

Immuno-Genetic, Inflammation, Retro-Virus, Environment

I-Give
Start date: November 2014
Phase: N/A
Study type: Interventional

Immunology combined to neurobiology now offer prominent tools to yield biomarkers, so far missing in psychiatry, and to design innovative treatment approaches based on the discovery of new molecular and cellular targets. As Bipolar Disorder and Schizophrenia are now known to be significantly associated with neuro-inflammation, the project I-GIVE will combine multidisciplinary approaches (clinical, viral, immunological, genetic) to explore a global hypothesis placing the Human Endogenous Retro-Virus, HERV-W, at the crossroads between susceptibility to environmental factors (such as winter-spring births, infections, urbanicity…) and genetic factors controlling immune responses. Thus I-GIVE will allow identification of new biomarkers and their correlation with clinical profiles and immuno-inflammatory/immuno-genetic markers, and description of patho-physiological mechanisms of a psychiatric disorder. In addition, I-GIVE should help to design innovative treatments and foster personalized psychiatry tailored to the needs of each patient. Notably, monoclonal antibodies anti-HERV-W Env will be assessed in a preclinical model for their ability to slow, stop, or even reverse the progression of the psychosis in patients. I-GIVE project should thus lead to major results that will have strong impacts on the scientific community, pharmaceutical industries and, in a longer term, on improvement of patients suffering Bipolar Disorder or Schizophrenia and their family.

NCT ID: NCT02876900 Completed - Schizophrenia Clinical Trials

Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.

HP-3070
Start date: August 2016
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.

NCT ID: NCT02874573 Recruiting - Schizophrenia Clinical Trials

Tocilizumab in Schizophrenia

Start date: September 2016
Phase: Phase 1
Study type: Interventional

This study is a Phase 1 clinical trial to determine the safety, tolerability, and efficacy of Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients with schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin G1 (IgG1) subclass. Tocilizumab is formulated as a concentrate for solution for infusion, and will be administered by intravenous infusion. The investigators propose a 12-week randomized controlled trial of tocilizumab, given in adjunct to antipsychotics, in N=20 stable outpatients with schizophrenia or schizoaffective disorder and evidence of increased inflammation in the peripheral blood (high-sensitivity C-reactive protein [hsCRP]>0.5 mg/dL). The investigators hypothesize that adjunctive treatment with tocilizumab will be associated with significant improvement in cognition compared to placebo in patients with schizophrenia, and baseline IL-6 levels are higher in tocilizumab-treated responders versus non-responders, and there will be greater decreases in hsCRP from baseline to week 12 in tocilizumab-versus placebo-treated responders, with response defined as ≥0.5 standard deviation (SD) improvement in cognition. Tocilizumab is administered as an intravenous infusion every 4 weeks. Following a screening evaluation, participants will receive three infusions of siltuximab, one at baseline, another at week 4 of the study, and another at week 8. The investigators will measure changes in cognitive function and symptoms over a 12-week period. Complementing previous positive clinical trials of non-steroidal anti-inflammatory drugs, this would be a "proof-of-concept" study that targeting specific cytokines is a viable treatment for schizophrenia. Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by Tadamitsu Kishimoto in the 1980s. In 1997, Chugai Pharmaceuticals began the clinical development of tocilizumab for the treatment of rheumatoid arthritis. Clinical studies for Castleman's disease and systemic juvenile idiopathic arthritis started in 2001 and 2002, respectively. Hoffmann-La Roche co-developed the drug due to a license agreement in 2003. On 11 January 2010, Tocilizumab was approved by the U.S. Food and Drug Administration (US FDA) as Actemra for the treatment of rheumatoid arthritis. The FDA approved tocilizumab for the treatment of systemic juvenile idiopathic arthritis for children from two years of age in April 2011.

NCT ID: NCT02874560 Completed - Schizophrenia Clinical Trials

Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia

Start date: August 12, 2014
Phase:
Study type: Observational

In a population of patients suffering from schizophrenia being treated for an episode of clinical destabilization and followed for a period of twelve months, the main objective is to evaluate the proportion of patients achieving functional remission and its relationship to clinical remission.

NCT ID: NCT02874482 Completed - Schizophrenia Clinical Trials

Cognitive and Emotional Factors in Visual Exploration Among Patients With Schizophrenia

SAILLANCE1
Start date: July 2014
Phase:
Study type: Observational

Background: Patients with schizophrenia are abnormally disturbed by information onsets, which may result in a disadvantage in filtering relevant information. It seems that they accord the same importance to all objects in a scene without taking into account the relevance of objects (cognitive salience) or their emotional charge (salience emotional). The paradigm of change blindness offers the interesting possibility of studying sensitivity to the sudden irruption of visual information with ecological stimuli in schizophrenia. An increased attentional capture by the irruption of visual information would suggest better performance in patients than in healthy controls. Moreover, patients are disturbed to processing of emotional information, in this way we would like to measure the impact of emotional salience on the visual exploration. Main aim: The main objective is to evaluate, if patients with schizophrenia quickly detect changes occurring on irrelevant objects in the understanding of the scene. Secondary objectives: To evaluate in patients with schizophrenia the impact of emotional salience using the same paradigm. To separate an explicit response (motors responses) with an implicit response (eye tracking measures). Methodology: 30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96 scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants' speed and accuracy in explicitly reporting the changes via motor responses and their capacity to implicitly detect changes via eye movements.

NCT ID: NCT02873208 Completed - Schizophrenia Clinical Trials

A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Start date: August 7, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

NCT ID: NCT02869334 Completed - Schizophrenia Clinical Trials

Remediation of Auditory Recognition in Schizophrenia With tDCS

Start date: June 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder.

NCT ID: NCT02868879 Completed - Schizophrenia Clinical Trials

Anatomical and Structural Connectivity in Two Psychotic Phenotypes : Periodic Catatonia and Cataphasia

Start date: September 25, 2006
Phase:
Study type: Observational

The different subtypes of Schizophrenia might have a disordered connectivity as their final common pathways. The investigators will use multimodal structural MRI to assess anatomical connectivity on the one side and its functional consequence on functional connectivity on the other side to assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with control subjects. The coherence between structural and functional anomalies will be especially studied.