Active clinical trials for "Schizophrenia"

This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment phase with a 14(±2)-day safety follow-up.

m-RESIST is an m-health intervention program aimed to develop, test and evaluate a tool to allow patients suffering from treatment-resistant schizophrenia to self-manage their condition. This may facilitate acceptance and involvement of patients with their own treatment, as well as of caregivers. Moreover this programme could provide a new tool to the psychiatrist, psychologists working together with other health care professionals, to better monitor patients, through a personalised and optimised therapeutic process. The present document corresponds to the pilot field-trials phase included in a three year European research project, co-funded by the Horizon 2020 Framework Programme of the European Union (grant agreement nº 643552). This document summarises the protocol of the whole therapeutic process, specifying all the procedures included in the program. This protocol will be implemented in three countries: Israel, Hungary and Spain, in order to test acceptability, usability, satisfaction and changes in the quality of life reported by the end-users.

Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual (ETP) in helping people with schizophrenia improve their social cognition and social functioning so specially on negative symptoms. Many studies show a connection between negative symptom and social cognition in schizophrenia.

The ISST study investigates whether integrated social cognitive remediation and social behavioral skills therapy is more efficacious in improving functional outcome and treatment adherence than an active control treatment comprising drill-and-practice oriented neurocognitive remediation.

People with severe mental illness have an increased risk of somatic comorbidities such as metabolic syndrome, obesity, hypertension, dyslipidemia and diabetes mellitus, which induce an increased risk of early mortality, mainly because of cardiovascular diseases. These high cardio-metabolic risks result of several factors such as lack of access to medical care, a poor and unbalanced nutrition, physical inactivity and smoking but they are also exacerbated by antipsychotic medications and anti-epileptic mood stabilizers prescribed to treat their psychiatric disorder. These prevention and awareness interventions in lifestyle are most often implemented in ambulatory stabilized patients. Also weight gain occurs in the early months of treatment. The therapeutic education program evaluated in this study seeks to potentiate the effectiveness of these preventive measures through early awareness in hospitalized patients. Finally, this study aims to compare the efficacy of two early and short programs on health behavior: first a program inspired by motivational interviewing and behavioral psychotherapy and secondly an exclusively educational program (information, formative assessment).

This project aims to provide the proof of concept for transcranial direct-current stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed antipsychotic medication. An early optimization of the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In this study, stimulation is an add-on treatment to antipsychotic medication, and will be used in a broad variety of patients, i.e. in patients with varied durations of illness, various symptoms profiles, and various levels of treatment response. This in turn will allow the determination of the extent to which results can be generalized to varied patient populations, as well as the extent to which various therapeutic targets (e.g. different symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS. Despite interesting preliminary results, our team is unable to describe optimal non-invasive brain stimulation (NIBS) response markers. This study is a randomized, double blind, controlled, French multicenter study (11 centers). The investigators plan to include 144 patients with persistent symptoms in schizophrenia. Seventy two subjects will receive active tDCS and 72 subjects will receive sham tDCS (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders, defined as a decrease of at least 25% of symptoms as measured by a standardized clinical scale score (PANSS) between baseline and after the 10-session tDCS regimen. Furthermore, the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers. An analysis of the effects on cortical activity and plasticity markers could be an interesting approach.

Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) as a treatment for auditory hallucinations in patients with schizophrenia.

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.

The aim of this study is to evaluate the therapeutic efficacy of tDCS (transcranial direct current stimulation) for treatment of negative symptoms in patients with schizophrenia. The proposed design is a clinical trial, randomized, double-blind, placebo-controlled study. Participants will receive ten sessions of active or sham stimulation in five consecutive days. 100 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention: 2, 4, 6 and 12 weeks after. As objectives, the investigators expect to see a clinical improvement of negative symptoms through scales PANSS (Positive and Negative Syndrome Scale), Calgary, Auditory verbal hallucinations, SANS (Skills for Assessment of Negative Symptoms), and expect improvement on computerized cognitive tests. Another goal is to see improvement in biological markers related to schizophrenia, plasma and DNA will be stored.

This study will examine the benefits of transcranial direct current stimulation (tDCS), a new tool that is being developed as a safe and non-invasive neurostimulation method, for improving neurocognitive and social cognitive functions in schizophrenia. This procedure is non-invasive and painless and it results in increase or decrease of spontaneous neuronal firing in the brain. Its safety and beneficial effect on cognition has been demonstrated in healthy individuals and several clinical populations. In this pilot study, the investigators will examine the effect of tDCS on cognitive functions in 40 individuals with schizophrenia. Each participant will arrive for three visits, with approximately one week between each visit. During the first visit, participants will be interviewed about their psychiatric symptoms, personal life experiences, and emotional well being by a specially-trained interviewer. On each of the three visits, participants will receive one of three stimulations: a type of tDCS designed to increase neuronal firing, an alternative form of tDCS designed to decrease neuronal firing, and a sham tDCS (stimulation with no current). Immediately following the stimulation, participants will be asked to complete measures of mental abilities, including tests presented on a computer screen and paper-and-pencil tests. During each visit, participants will also undergo a standard measure of brain activity (EEG) while listening to tones. The first visit will last approximately five hours, and the other two visits will last approximately four hours each. The project will take approximately two years to complete.