View clinical trials related to Schizophrenia.
Filter by:To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
Schizophrenia is a severe psychiatric condition that is associated with significant distress and disability. In addition to cognitive difficulties in domains such as attention, memory, and problem-solving, individuals with schizophrenia can experience visual-processing abnormalities, including impairments in visual acuity, low-contrast stimulus detection, and perceptual organization (i.e., perceiving visual information in an organized "perceptual whole"). These visual impairments are clinically significant, with research indicating that specific visual-processing alterations are significantly related to poorer performance on higher-level cognitive tasks, impaired facial emotion recognition, impaired reading ability, and worse functional outcomes. Despite such findings, very few studies have evaluated the therapeutic potential of interventions that are specifically designed to improve visual processing ("visual remediation") for individuals with schizophrenia. Thus the aim of this study is to evaluate the efficacy of a computerized visual perceptual training program that targets low- and mid-level visual processes to improve visual, cognitive, and emotion-recognition functions in outpatients with schizophrenia through a small randomized controlled trial. The investigators will recruit up to 40 individuals with schizophrenia or schizoaffective disorder who are receiving treatment in Rutgers University Behavioral Health Care (UBHC) Partial Hospital Program; half will be randomized to receive the computerized visual training, which will be delivered in small groups over a period of 12-14 weeks. The specific aims of this study are to collect preliminary data on: 1) the feasibility of participant recruitment and retention, and tolerability of the treatment components of the study; and 2) the efficacy of computerized visual training (VT) to improve low- and mid-level visual processes, and higher-level cognitive and social-cognitive performance. Based on preliminary data, the investigators hypothesize that the target number of participants will be successfully recruited and engaged in the VT intervention (n=16) and control condition (n=16), and that the participants who receive VT will demonstrate greater improvements on measures of low- and mid-level visual, higher-level cognitive, and social-cognitive functions compared to those who receive standard partial-hospital care without VT. The results of this initial trial will be used to inform the design and application for funding of a larger-scale investigation of visual remediation for individuals with schizophrenia.
Experience dependent plasticity is a fundamental property of the brain. It allows neural systems to adapt in response to environmental input and subserves the vital functions of learning and memory. Deficits in plasticity are also thought play a causal role in the pathophysiology of several psychiatric disorders, specifically schizophrenia (SZ). Treatments that can probe or even enhance plasticity have potential to be of great clinical and research value. Non-invasive neuromodulation via transcranial direct current stimulation (tDCS) is a promising method for modulating neural plasticity. tDCS delivers low-intensity direct current to cortical areas, thereby facilitating or inhibiting neural activity in a polarity specific manner. Due to its low cost and safety, tDCS has been employed in a wide variety of studies, but much remains unknown regarding its mechanism of action in humans. Experiments carried out in animal and tissue models indicate that tDCS modulates synaptic plasticity mechanisms of long term potentiation and depression (LTP/D), however, these findings have never been translated to human subjects, limiting the practical utility of the research. Recently developed electroencephalographic (EEG) based measures now allow the interrogation of synaptic plasticity non-invasively in humans, making it possible to explore the effects of tDCS on human brain plasticity.
The treatment of schizophrenia is challenging as the existing medications improve only the positive symptoms with the limited benefit on cognitive and negative symptoms which have a large bearing on the functional outcome. Recent research has suggested the association of low level of vitamin D with schizophrenia but studies are few and marred by mixed results. Thus, we propose to evaluate the effect of weekly vitamin D3 supplementation in patients with first-episode schizophrenia through a randomised doubled blind placebo controlled design.Fifty-six participants of either sex (19 - 50 years) with schizophrenia having vitamin D insufficiency/deficiency (< 30 ng/ml) will be randomly supplemented with Vitamin D3 or placebo for 8 weeks in 1:1 pattern. The clinical treatment i.e., antipsychotic medications will be continued as usual within the two groups. Participants in both the groups will be assessed at study entry, at the end of the 04 and 08 weeks (after completing supplementation) on the Positive and Negative Syndrome Scale (PANSS), Computerized Neurocognitive Battery (CNB) & Clinical Global Improvement (CGI) subscale (CGI-I). Raters will be blind to the group assigned to participants. Side effects will be monitored at every visit. The serum levels of vitamin D will be measured at baseline and at the end of 08 weeks.
This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia. Part 1 Objectives: There are two primary objectives for Part 1 of this study: 1. To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults, and; to determine the optimal dose to be used in Part 2 of this study. 2. Sample size re-assessment to evaluate the final sample size needed to proceed with Part 2 of the study The secondary objective of the Part 1 of this study is to evaluate the safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), in combination with clozapine. Part 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), in combination with clozapine.
Schizophrenia affects a significant proportion of the population and current levels of understanding of the illness is inadequate to treat it effectively. Converging lines of evidence suggest that neuroinflammation occurs in schizophrenia, and specifically over-activity of brain-resident immune cells called microglia. It is however unclear whether activated microglia play a primary role in schizophrenia, or whether this is a secondary phenomenon of no pathophysiological significance. The investigators therefore plan to test the effect of a monoclonal antibody (natalizumab) on psychotic symptoms in a cohort of first episode psychosis patients.
Background: The Human Brain Collection Core (HBCC) collects brain and other tissues. They get these from deceased people who may or may not have had psychiatric disorders. The next of kin gives permission for researchers to get the tissues. Researchers want to collect medical details of people whose brains are donated. They also want to use the donated tissue to study brain chemistry and structure. This could lead to better treatments for mental illness. Objective: To create a collection of human brain tissue to learn about the causes and mechanisms of mental disorders. Eligibility: People willing to donate their deceased relative s brain tissue. The deceased person could not have had any of the following: Severe mental retardation Long-lasting seizure disorder Infections that affect the brain Decomposition Brain damage Being on a respirator for more than 12 hours Major sepsis Serious renal or hepatic disease Certain dementias and degenerative diseases Design: Medical Examiner s Offices will screen donors who have recently died. Some others will be screened by hospitals or funeral homes. Participants will be the next of kin. They will give consent for HBCC to obtain brain tissue from the deceased person. The tissue will be frozen for future research. Participants will have a 30-minute phone call. They will answer questions about the deceased person s medical and psychiatric conditions. They will answer questions about the person s use of medicines and drugs. Participants will be contacted by a social worker. They will be asked for permission to access the deceased person s medical records.
This study compares the efficacy and effectiveness of two of the second-generation antipsychotics (SGAs) most used in our society in the treatment of schizophrenia (Aripiprazole and Risperidone) and the investigators do within an assistance program of early-stage psychosis individuals of the Community of Cantabria, clinical reference for the treatment of this disease in the Spanish Autonomous Community. Patients are included in a prospective naturalistic study, open flexible-doses and randomized into one of two possible patterns of treatment that includes the protocol.
This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the ten years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.
This is a 12-month open-label randomized controlled study. Patients with schizophrenia and violence risk under the government supervision will be enrolled in the study. A community-based long-acting antipsychotics-treated management model will be applied to the experimental group, which means that professional psychiatrists will provide guidance to primary-level mental health workers on the psychotic treatment, and monthly-injected long-acting antipsychotic, paliperidone palmitate, will be used in the schizophrenia treatment. Every subject in experimental group will be equipped with an intelligent robot capable at push-to-talk and push-to-view, allowing the patients and caregivers to contact doctors for assistance at any time. The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. Subjects in control group will be treated with oral antipsychotics or other conventional medication.