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Schizophrenia clinical trials

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NCT ID: NCT03702933 Recruiting - Schizophrenia Clinical Trials

D-serine in Schizophrenia

DSRSZ
Start date: September 1, 2018
Phase:
Study type: Observational

This study will assess the effects of D-serine adjuvant treatment to the ongoing pharmacological treatment of schizophrenia patients that are resistant to treatments.

NCT ID: NCT03693794 Recruiting - Schizophrenia Clinical Trials

A Study in Italy About Evidence Based Psychosocial/Rehabilitative Interventions in Patients With Early Schizophrenia Treated Continuously With Antipsychotics

ESCHILO
Start date: December 15, 2017
Phase:
Study type: Observational

This is a prospective, observational, naturalistic study conducted according to Italian law. The Investigators are interested in observing how often Evidence Based (EB) psychosocial and rehabilitative interventions are actually offered to patients in the real world clinical practice of psychiatric Italian services able to deliver this kind of treatments, focusing on a cohort of patients with recent onset schizophrenia, for whom delivery of integrated treatments is especially recommended, treated continuously with Long Acting Injection (LAI) antipsychotics. The primary objective of this study is to explore the level of implementation of EB psychosocial/rehabilitative treatments during a prospective 12-month period in patients with recent onset schizophrenia (≤ 5 years) being treated with a LAI Antipsychotic in Psychiatric Departments with expertise in the application of such interventions and to describe the reasons of implementing the particular EB psychosocial intervention and the clinical-functional characteristics of patients assigned to them. The prospective design is strictly required both for allowing consistent definition and application of such interventions and for describing reliably the characteristics of patients assigned to them. Secondary objectives are to describe the reasons for the choice of the specific assigned psychosocial intervention (if any) and the clinical and functional treatment outcomes of patients assigned or not-assigned to EB psychosocial therapies.The assignment of a patient to any particular treatment is not decided in advance by the study protocol, but falls within current clinical practice. Inclusion criteria are: - Patients with schizophrenia (F20 according to ICD-10 version 2013) - Onset of schizophrenia, defined as the first onset of symptoms that required specific antipsychotic treatment or hospitalization, as derived from anamnesis or available clinical documentation, not more than 5 years before study entry - Age between 18 and 40 years - Patients under treatment with a LAI on the basis of physician's decision (LAI started no longer than 6 months before study entry) and clinically stable (no relapse requiring hospitalization or change of treatment due to clinical worsening) during the last 1 month. Primary outcome of interest ("endpoint") is percentage of patients within the total study population who have been assigned to any EB psychosocial/rehabilitative treatment (listed below) for at least 1 month consecutively during the 12-month observation period (given the heterogeneity of interventions, this is an arbitrary duration which may reliably indicate a significant exposure to a given intervention). The percentage of each type of psychosocial intervention delivered together with frequency of sessions and length of treatment, and the reasons (categorized) given by the clinicians to justify the selected psychosocial intervention as well as the clinical-functional characteristics of patients assigned to them will be described. Patient assignment to the different interventions and their delivery will be traced in the patients' clinical charts. A list of key-words to describe each intervention will be provided in order to identify reliably and univocally the activities delivered. Secondary endpoints: - Sociodemographic information - Percentage of patients assigned during the 12-months period to at least one non EB intervention for at least 1 month consecutively (given the heterogeneity of interventions, this is an arbitrary duration which may reliably indicate a significant exposure to a given intervention) but not to any of the EB interventions. - Percentage of relapses - % of patients who discontinue drug treatment (for ineffectiveness, side effects or other reasons and patient/physician decision) and/or psychosocial interventions (for team or patient decision) - Changes in clinical, cognitive, functional and quality of life measures Additional endpoints: - Health economic information collected through 3 specific questionnaires: detection of i) health resources consumption for the care of the disorder (direct costs, eg. drug cost, hospitalization, emergency visits, Day hospitals, General Physician visits…) and assessment of indirect costs through evaluation of : ii) patient's potential income loss, absenteeism and presenteeism to estimate work productivity, daily activity impairment due to the mental illness and of iii) caregiver's potential income loss, commitment of time for the patient's care, absenteeism and presenteeism to estimate work productivity, daily activity impairment because of the patient's mental illness

NCT ID: NCT03675750 Recruiting - Schizophrenia Clinical Trials

Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

Start date: July 1, 2018
Phase:
Study type: Observational

The study is aimed to assess the severities of hyperprolactinemia caused by antipsychotic drugs and the effects of the duration of hyperprolactinemia on bone metabolism in schizophrenia patients.

NCT ID: NCT03649581 Recruiting - Schizophrenia Clinical Trials

Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders

NeuroSplitsz
Start date: February 28, 2019
Phase: N/A
Study type: Interventional

The current diagnostic criteria for schizophrenia and other psychotic disorders are relatively broad and lack precision. Therefore, distinct diseases may be grouped together under the same diagnostic category, although these diseases may differ according to their clinical expression, prognosis and perhaps their physiopathological causes. We think that identifying subforms of psychotic disorders that are more homogeneous will better enable to understand their respective physiopathological causes and find personalized treatments. This study will compare two subforms of psychotic disorders that have been clinically distinguished in the 1970s. These phenotypes have however not been validated yet using scientific investigations. Using clinical assessments, cognitive evaluations and neurophysiological measures (fMRI) investigating the domains of affect and psychomotoricity , we expect that these two subforms will differ on their clinical, cognitive and neurophysiological characteristics, namely: hebephrenia will be associated with deficits on the affect markers , and respect psychomotoricity (catatonia scales, tests assessing movement planification) whereas the opposite pattern will be observed for periodic catatonia.

NCT ID: NCT03632278 Recruiting - Clinical trials for Schizophreniform Disorders

Mindfulness Psychoeducation Program for Schizophrenia

Start date: June 3, 2018
Phase: N/A
Study type: Interventional

The study is the first pilot randomised controlled trial (RCT) to explore the feasibility and efficacy of Mindfulness-based psychoeducation in emotion regulation and related depressive and anxiety symptoms in people with schizophrenia.

NCT ID: NCT03627377 Recruiting - Obesity Clinical Trials

Multi-component Intervention for Diabetes in Adults With Serious Mental Illness

MIDAS
Start date: December 28, 2018
Phase: N/A
Study type: Interventional

Persons with schizophrenia and other serious mental illnesses have a high risk for type 2 diabetes and an increased risk of premature mortality compared to the general population. The goals of the proposed study are to implement a multimodal lifestyle intervention to reduce that risk in these individuals living in residential care facilities, a common housing modality for people with serious mental illnesses. If successful, this intervention will lead to reduction in excess medical comorbidity and mortality in persons with serious mental illnesses.

NCT ID: NCT03601026 Recruiting - Schizophrenia Clinical Trials

Genetic Counselling in the Prevention of Mental Health Consequences of Cannabis Use

IMAGINE
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Severe mental illness (SMI) refers to the most burdensome psychiatric conditions. The need to pre-empt the onset of SMI is pressing because once SMI develops, quality of life is poor and available treatments have limited efficacy. Most risk factors for SMI are either unchangeable (e.g., genetics) or difficult to alter (e.g., low socio-economic status). In contrast, cannabis use is one specific risk factor that could be avoided. Certain individuals are more vulnerable to the harmful effects of cannabis. Genetic factors can help us identify these high-risk individuals. One in three individuals are carriers of a higher-risk genetic variant, and cannabis users with this genotype are at up to 7-fold increased risk of developing schizophrenia. In our study, genetic counselling will be provided to participants by a board-certified genetic counsellor. During the genetic counselling session, participants will have the option to receive their genotype. Participants will be counselled regarding their individualized risk of developing and of not developing SMI based on family history, whether or not they choose to use cannabis, and genotype (if the participants accept the genetic test results). The investigators hypothesize that this intervention will reduce exposure to cannabis compared to the youth who are not offered the intervention.

NCT ID: NCT03542903 Recruiting - Schizophrenia Clinical Trials

ECT in Ultra-resistant Schizophrenia

SURECT
Start date: July 4, 2018
Phase: N/A
Study type: Interventional

The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6 months in most studies with follow-up). The literature identified a high relapse rate of 32% in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the relapse is partially known. In an empirical way, experts recommend protocols of prevention of the relapse going from 6 to 12 months. Nevertheless, the profit of a long cure (12 months) compared with a short cure (6 months) was never determined. Therefore, the investigators decided to lead a prospective randomized controlled study in order to compare the response rates between the two strategies of clozapine and ECT combinations applied to URS patients. The treatment consisted either in a short therapy of six months or a longer course of therapy of twelve months. To the investigators' knowledge, it is the first study which compares two ECT strategies (both the short duration and the longer one) for the treatment of URS patients.

NCT ID: NCT03525054 Recruiting - Psychosis Clinical Trials

Semantic and Syntactic Computerized Analysis of Free Speech

ASESID
Start date: May 18, 2018
Phase:
Study type: Observational

Subtle speech disorganization could be predictive of a transition to schizophrenia of ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify specific linguistic markers of the psychotic transition to validate a french predictive model of this transition using computerized speech analysis techniques

NCT ID: NCT03523741 Recruiting - Schizophrenia Clinical Trials

Therapeutic Drug Monitoring for Individualized Clozapine Therapy

Start date: June 13, 2018
Phase:
Study type: Observational

The purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment