View clinical trials related to Psychotic Disorders.
Filter by:This study is a Phase 1 clinical trial to determine the safety, tolerability, and efficacy of Siltuximab (Sylvant) as an adjunct to antipsychotic medications in stable outpatients with schizophrenia. Siltuximab (structural formula C6450H9932N1688O2016S50) is a recombinant chimeric (human-murine) anti-human interleukin-6 (IL-6) monoclonal antibody. Siltuximab is formulated as a concentrate for solution for infusion, and will be administered by intravenous infusion. The investigators propose a 9-week randomized controlled trial of siltuximab, given in adjunct to antipsychotics, in N=30 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 siltuximab will be associated with significant improvement in cognition compared to placebo in patients with schizophrenia, baseline IL-6 levels are higher in siltuximab-treated responders versus non-responders, and there will be greater decreases in hsCRP from baseline to week 6 in siltuximab-treated versus placebo-treated responders, with response defined as ≥0.5 SD improvement in cognition. Siltuximab is administered as an intravenous infusion every 3 weeks. Following a screening evaluation, participants will receive three infusions of siltuximab, one at baseline, another at week 3 of the study, and another at week 6. The investigators will measure changes in cognitive function and symptoms over a 9-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. Janssen Pharmaceuticals, Inc. began the clinical development of siltuximab for the treatment of multicentric Castleman's disease, a rare blood disorder. Other clinical studies with siltuximab have been conduced for patients with B-cell non-Hodgkin's lymphoma, multiple myeloma, and ovarian cancer. In April 2014,siltuxiumab was approved by the U.S. Food and Drug Administration (US FDA) as Sylvant for human immunodeficiency virus (HIV)-negative and human herpesvirus-8 (HHV-8)-negative multicentric Castleman's disease.
The main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events.
Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. However, to date, several randomized controlled trials (RCTs) have shown no differences in clinical outcomes between once- and twice-daily dosing of various antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life. This would apply to clozapine as well; however, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. To address this gap in the literature, the investigators shall conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.
The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance directive which involves the patient, the healthcare team, their relatives and a third party caregiver as intermediary for the project. The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care. Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months and again where there is an unplanned psychiatric readmission that lasts beyond two weeks. Single blind multicentre randomised trial with parallel control groups. Effectiveness study of a psychiatric care strategy.
The purpose of this trial is to explore parent-child interactions in parents with and without psychosis, and ascertain whether a brief (10 week) supported self-help parenting program offered to parents in their own homes can help improve parents' self-efficacy and general well-being, as well as interpretations of their parent-child relationship and child behaviour in children who are 3-10 years old.
This a randomized double-blind placebo controlled trial which aims to determine the beneficial effects of minocycline augmentation to clozapine in partial responders to Treatment Resistant Schizophrenia (TRS).
Objectives 1. to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry. 2. to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional.
The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent than in the urban areas of the country. The population study aims at examining complexities of environmental, hereditary, lifestyle, and social factors as determinants and predisposing factors for morbidity, health, and quality of life. The study will cover physical, mental, and social dimensions and examine family patterns and subgroups. The study will provide baseline information for later follow-up.
Background Paliperidone is an active metabolite of risperidone, both of which are antipsychotic agents for treatment of schizophrenia and related psychotic disorders. Pharmacogenetic studies have revealed that the efficacy and side effects of antipsychotic agents are related to polymorphisms of specific genes, however, there are just a few related studies on paliperidone. The current study aims to evaluate whether pharmacogenetic markers related to risperidone and genetic markers associated with schizophrenia have effects on the clinical effectiveness of paliperidone treatment. The study also uses changes of event-related potentials (ERP) as indices for clinical efficacy. Methods It is a prospective, open-label, non-randomized and uncontrolled clinical trial to study the efficacy and side effects of 6-week paliperidone ER treatment for patients with schizophrenia or schizoaffective disorder. The first three weeks of treatment has to be inpatient treatment. In the first two weeks, participants will take 9 mg paliperidone ER daily. Then the dose of paliperidone can be adjusted to within the range of 6-12 mg per day. Efficacy indicators include symptom severity, global functioning, and ERP. Side effect indicators include common side effect evaluate, extrapyramidal symptoms, metabolic profiles, hormonal change, and bone metabolism indices. Participants will also receive examinations for blood drug concentration, genetic polymorphisms, and epigenetic markers.
The perception of music requires coordinated neural activities in distributed multi-functional centers across both hemispheres. The association between musical abilities and other general cognitive functions have been studied in several populations with inconsistent results. Schizophrenia is a major mental disorder that is strongly associated with cognitive deficits. These often appear before the onset of psychotic symptoms and persist throughout effective treatment of positive and negative symptoms. Like other disorders of psychosis, schizophrenia features general deficits in auditory memory and sensory processing. Recently, Sawada et al. (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese schizophrenic populations. They both used a standardized assessment for amusia called Montreal Battery of Evaluation of Amusia (MBEA) and found marked impairments in perception of scale, contour, interval, rhythm, meter and memory. Both studies showed that deficits in music perception were associated with cognitive deficits and negative symptoms. In regards to positive symptoms, Wen et al., but not Sawada et al., found a significant association. The present clinical study will assess musical abilities using the MBEA in a Canadian population with and without refractory psychosis. It will explore associations between musical deficits, positive and negative psychiatric symptomology and cognition. The patient population will have a diagnosis of schizophrenia, schizoaffective disorder, affective disorder with psychosis or non substance-related psychosis who were referred to the British Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of antipsychotics. A focus on refractory psychosis may provide greater insights because these patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It will also be valuable to administer the MBEA assessment on a Canadian population, because the test was originally intended for Western populations and its musical phrases were designed with Western tonalities.