View clinical trials related to Schizophrenia.
Filter by:Although antipsychotic is effective for schizophrenia, however, still certain proportion of patients were not responsive to treatment. Treatment resistant schizophrenia (TRS) is accompanied by function decline and heavy burden. In recent decades, the biological mechanism of schizophrenia extended from dopamine theory to the role of glutamate system. This shift could be an alternative pathway to developing the treatment of TRS. Sodium benzoate (SB) could be an option as a glutamatergic agent for the patients with TRS. However, most evidence of SB is for treating patients with schizophrenia and other mental disorders but the evidence for treating patients with TRS is scarce. To predict the treatment response of SB will be an urgent topic in the future. Little is known about the precise medicine for treating patients with TRS. The present project will extend our pilot randomized clinical trial on SB for TRS. A total of 90 patients with TRS will be enrolled from three centers and will be assigned to 8 weeks of treatment with SB or placebo (2:1). A comprehensive battery of potential markers will be employed, including 1H- magnetic resonance spectroscopy (MRS), brain functional connectivity, genotyping, immune biomarkers, cognitive function, and clinical characteristics. The efficacy of SB on TRS will be confirmed in this project. Predictors for treatment response will be identified. Artificial intelligence algorithms will be used for probing the feasibility of precision medicine.
Schizophrenia (SZ) is a broad clinical entity characterized by different subjective symptoms,behavioural signs, and disease course. Research has pointed to numerous biological indicators tentatively associated with neurocognitive dysfunction, brain structural and neurochemical alterations. Cognitive deficits occur as early as the prodromal phase of the illness and significantly determine its outcome. Pathophysiologically, SZ is regarded as a disconnectome disorder in which frontal and temporal brain regions are functionally disconnected, which contributes substantially to the development of cognitive dysfunction. Impaired connectivity is related to synaptic (microconnectivity) and myelin (macroconnectivity) plasticity. With design-based stereology, a decreased number of oligodendrocytes (OLs) in the CA4 hippocampal subregion as the basis for disturbed myelination and impaired cognition, but also a decrease in the prefrontal cortex were observed. Animal studies demonstrated that clemastine enhances remyelination by increasing the differentiation of oligodendrocyte precursor cells (OPCs) and showed that aerobic exercise increases the rate of remyelination and proliferation of OPCs; this clinically meaningful effect of aerobic exercise is stronger in combination with clemastine. Furthermore, aerobic exercise improves everyday functioning, measured by the Global Assessment of Functioning (GAF) scale, and cognitive dysfunction in SZ and increases hippocampal volume, especially the volume in the hippocampal CA4 subregion. This regional volume change correlates negatively with global and cell-specific polygenic risk scores (PRSs), indicating that OPCs are involved in the genetic risk mechanisms and disturbed plasticity underlying SZ. In patients with multiple sclerosis, 90 days' administration of clemastine fumarate 10.72 mg/day, corresponding to clemastine 8 mg/day, significantly decreased the P100 latency delay of visual evoked potentials (VEPs) as a sign of myelin repair. In a bicentric, randomized, double-blind, controlled phase IIb clinical trial with a 2-arm parallel group design in patients with SZ, the study will compare the effects of aerobic exercise training plus clemastine vs. aerobic exercise training plus placebo over a period of 3 months on 1) everyday functioning and 2) working memory as primary outcomes.
This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention.
The study is to evaluate the safety, tolerability, and PK characteristics following single administration of HS-10509 in healthy adults, and multiple administrations of HS-10509 in patients with schizophrenia. Participants will have HS-10509 tablets or placebo once in the single ascending dose (SAD) part or once daily for 28 days in the multiple ascending dose (MAD) part.
Adults with serious mental illnesses (such as schizophrenia and schizoaffective disorders) often experience a range of cognitive difficulties (such as memory, problem solving difficulties) that affect their ability to lead meaningful life roles. Cognitive remediation is an intervention to address cognitive difficulties in this group of mental health service users. Its implementation in less well-resourced community-based settings is less well-studied. Therefore, the aims of the study are: - To investigate the effects of cognitive remediation on various cognitive skills (such as attention, memory, problem-solving, facial expression recognition, taking others' perspectives etc), for participants with schizophrenia or schizoaffective disorders in community mental health settings. - To investigate if factors such as participants' motivation for engagement and social interaction can affect changes in cognitive skills and functional ability. Participants in the treatment group will attend computer-based cognitive exercises to improve their cognitive skills. They will also participate in group sessions facilitated by therapists to learn how to utilize strategies learned from the computer sessions in their daily lives. Participants in the control group will attend the usual rehabilitation activities in their respective community-based psychiatric rehabilitation centers. This research study will compare the differences in their cognitive performance, functional ability and recovery immediately after the intervention and 8 weeks later.
This project aims to introduce a new psychoeducation program that helps individuals with schizophrenia to recover subjectively. The program's effectiveness will be evaluated through a randomized controlled research design. The goal is not only to emphasize clinical recovery but also to highlight the importance of individual recovery and promote its implementation. In this context, the following hypotheses have been formulated. Research Question: 1) Does recovery-based psychoeducation have an impact on the subjective recovery level in individuals diagnosed with schizophrenia in remission? Hypotheses: H0a: Recovery-based psychoeducation does not affect the subjective recovery level in individuals diagnosed with schizophrenia in remission. H0b: Recovery-based psychoeducation does not effect on psychological resilience in individuals diagnosed with schizophrenia in remission. H0c: Recovery-based psychoeducation does not effect on hope in individuals diagnosed with schizophrenia in remission. H1a: Recovery-based psychoeducation affects the subjective recovery level in individuals diagnosed with schizophrenia in remission. H1b: Recovery-based psychoeducation has an effect on psychological resilience in individuals diagnosed with schizophrenia in remission. H1c: Recovery-based psychoeducation has an effect on hope in individuals diagnosed with schizophrenia in remission.
Within the schizophrenia population, there are individuals that respond to first-line antipsychotic treatments while others do not. The availability of muscarinic M4 subtype receptors (M4R) may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not. The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls. In addition, M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures. This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options, particularly for cognitive deficits and negative symptoms.
The main aim of this study is to investigate emotional regulation in individuals with schizophrenia using a qualitative methodology (semi-structured interview) and, therefore, from the person's point of view. Given the qualitative nature of the methodology used in this study, the investigators have no specific hypothesis. The investigators have a general hypothesis suggesting that the patients' discourse will enable us to highlight the emotional regulation difficulties described in the literature.
The purpose of this research study to test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). The aims include determining whether E-CBSST is feasible and increases Cognitive Behavioral Social Skills Training (CBSST) Skills Learning to a level that will lead to a clinically meaningful improvement in functioning.
One in three patients with schizophrenia experiences hallucinations that are refractory to conventional pharmacotherapy. For refractory auditory hallucinations, transcranial direct current stimulation -tDCS- has been proposed as a novel therapeutic approach. Although promising beneficial effects on auditory hallucinations have been found by targeting the left frontal and temporoparietal cortex, the high variability observed in clinical response leaves much room for optimizing stimulation parameters. For instance, options should go beyond the left temporoparietal junction as a unique and single target of hallucinations, taking into account the personalization of the targeting based on the actual brain networks involved in hallucinations, including those beyond the auditory modality, as well as multimodal hallucinations. The present study will take advantage of recent technological developments to propose a personalized therapeutic strategy to alleviate hallucinations in schizophrenia. This will involve: - the simultaneous targeting of multiple brain regions with High-Definition (HD)-tDCS, which is known for its precise and longer-lasting effects compared to conventional tDCS. - and the fMRI-capture of hallucinations, using a precise and reliable data-driven approach to identify the functional brain networks recruited during hallucinations. The aim of the study is to assess whether repeated sessions of HD-tDCS guided using the fMRI capture of hallucinations can reduce multimodal hallucinations in patients with schizophrenia, compared to sham sessions of HD-tDCS.