Active clinical trials for "Psychotic Disorders"

A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a step-wise clinical approach for the treatment of ultra high risk patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.

This study uses mixed methods to investigate the implementation of digital cognitive behavioural therapy for insomnia (Sleepio) in a first episode of psychosis service (FEP). Interviews will be conducted with keyworker clinicians and service users to consider their expectations for digital sleep intervention. The rates of recruitment into the study, eligibility, completion of baseline measures, completion of the intervention sessions, attrition from the intervention and completion of follow up measures will be recorded. Interviews will be conducted with keyworker clinicians and service users to consider their experiences of digital sleep intervention. The primary outcome will be a logic model describing factors acting upon the implementation of Sleepio in this population. The investigators will provide signal data in relation to changes in insomnia severity, psychosis symptomatology, and general mental health.

Yoga and mindfulness are considered complementary and alternative healthcare options that involve breathing techniques, relaxation, and bodily postures (yoga only). Research has shown a positive effect of these on depression, quality of life, and other symptoms of psychosis. As an 8-week pilot study, the goal is to offer yoga and/or mindfulness online and to explore the effect on recovery and quality of life for people with psychosis.

A randomized controlled, prospective, two-armed, mono-centric, assessor-blinded clinical trial will serve to generate preliminary data on the efficacy and safety of modified psychodynamic therapy (MPP-S) in stabilized patients after the first or subsequent episodes of schizophrenia or schizoaffective disorder.

As of late Integrated Care Pathways (ICPs) have been shown to improve quality of care in the medical field with special attention given to mental health in particular. One aspect of metal health that has not seen the incorporation of ICPs is in the area of schizophrenia. Late life Schizophrenia (LLS) is defined as suffering from schizophrenia and being 50 years of age or older. The LLS-ICP study will look at the efficacy of an ICP in late life schizophrenia versus treatment as usual (TAU). Participants with LLS and having psychotic symptoms above a predefined threshold will be randomly assigned to a TAU group or an ICP group. The primary outcome measure will be reduction in symptom severity as measured by clinical global impression severity scale (CGI-S) and brief psychiatric rating scale (BPRS). If successful, this study will provide strong evidence to implement LLS-ICP across different inpatient and outpatient settings.

Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse.

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 aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with chronic schizophrenia or other psychoses. Cognitive deficits are a problem for many people with schizophrenia. This study will use computerized cognitive remediation training (which the participant can carry out at home) over a period of a few months.

Depressive mood and anxiety are prevalent in patients suffering from early psychosis. Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed Mindfulness-based intervention (MBI) as an effective option in handling depression and anxiety. There is a great possibility that MBI is also useful in depression and anxiety associating with early psychosis. Given that cost-effectiveness is widely concerned in Hong Kong or any other countries, a brief intervention is more favored. Current paper is a study protocol for a randomized controlled trial which assess the feasibility of a 7-week mindfulness-based intervention in patients with early psychosis targeting on their depressive mood and anxiety. In this RCT, 60 patients aged 18-65 with early psychosis less than 5 years' duration and mild depressive mood or anxiety will be invited to join this single blind randomized controlled trial. After baseline assessments, eligible participants will be, using third party simple randomization, randomly assigned to either the 7-week Mindfulness-based Intervention (MBI), or the psychoeducation group as control. The primary outcome is depressive mood and anxiety levels at post-intervention and 3 months. The secondary outcomes include life functioning, quality of life, other general clinical symptoms and mindfulness ability. Qualitative interviews will help evaluate and measure the feasibility of the intervention. Data will be analyzed according to the intention-to-treat principle. This randomized trial offers an insight into mindfulness-based intervention and its effectiveness on psychosis concomitants. It provides the foundation for future evaluation and implementation of an effective and cost-efficient treatment option.

This study will provide information regarding dopamine D2/D3 occupancy related with clinical/adverse effects in older people with schizophrenia and schizoaffective disorder. The results of this study will also show an appropriate dose range in order to evade undesirable adverse effects while deriving therapeutic effects, which will directly serve to guide physicians in clinical practice. Furthermore, the findings of this study will elucidate mechanisms underlying older people's increased sensitivity to antipsychotic drugs. In addition, the contribution of D2 and D3 in mediating antipsychotic response will be contrasted, using 2 radiotracers, which has never been tested in an older population. The hypotheses are as follows: First, clinical response (i.e., a ≥ 20% decrease in the Brief Psychiatric Rating Scale total score) will be achieved in older patients with occupancy that is lower than the threshold of 60% in historical young controls. Second, prolactin elevation and EPS will be detected in older patients with occupancies that are lower than the thresholds of 72 and 78% reported in historical young controls. Third, dopamine D2 receptor occupancy will be inversely correlated with subjective well-beings. Fourth, the binding potential and receptor occupancy will be at least 20% lower with [11C]-(+)-PHNO than with [11C]-raclopride in the caudate/putamen. Fifth, the binding of [11C]-(+)-PHNO in the globus pallidus will be higher than that of [11C]-raclopride.