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Psychotic Disorders clinical trials

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NCT ID: NCT03390712 Enrolling by invitation - Clinical trials for Schizophrenia Spectrum and Other Psychotic Disorders

Mirror-image Study of Paliperidone Palmitate and Risperidone Long-acting Injection

Start date: January 2, 2018
Phase: N/A
Study type: Observational

The primary objective of this single-center multi-site retrospective chart review is to determine if paliperidone palmitate and/or risperidone long-acting injection can decrease the number of psychiatric relapses following their initiation in an inpatient acute psychiatric unit compared to oral antipsychotic therapy and determine if one treatment is superior to the other in this regard. This study will utilize a mirror-image design and incorporate up to a 3 years of follow-up following the index admission. Secondary objectives of this study will be to determine the change in hospital resource utilization for psychiatric reasons following treatment initiation, and to determine the difference in time to relapse.

NCT ID: NCT03090503 Enrolling by invitation - Schizophrenia Clinical Trials

Effectiveness of Second Generation Antipsychotics in First Episode Psychosis Patients: 3-year Follow-up

PAFIP3_3Y
Start date: June 2014
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03090490 Enrolling by invitation - Schizophrenia Clinical Trials

10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals

ADARFEP_10Y
Start date: September 2014
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02916303 Enrolling by invitation - Schizophrenia Clinical Trials

Cost-effectiveness of Interventions in First-episode Psychosis

PAFIPEC
Start date: June 2016
Phase:
Study type: Observational

Schizophrenia has very significant economic consequences. Costs fall on many different parts of society, especially on individuals with schizophrenia and their families. The first five years after onset appears to be a critical period in which the symptoms are more responsive to treatment. In addition, if left untreated for a long time, psychosis can impact many areas of a person's life. The evidence base regarding the effectiveness of specialist early intervention services for psychosis has grown steadily and evidence from randomized controlled trials in Denmark, the United Kingdom and Spain has demonstrated the superiority of specialized early intervention programs over standard care on a broad range of outcomes including symptomatic and vocational, social functioning, and reduced inpatient care and treatment dropout, as measured over follow-up intervals of 2-3 years. Information about the cost-effectiveness of early intervention programs for first-episode psychosis is limited. The provision of such services requires investment by health departments and services, and the question of whether such services represent value for money has to date received little research attention. Only a few international studies, and none conducted in Spain, have investigated the cost effectiveness of early intervention in psychotic disorders at medium (3 years) and long-term (up to 10 years). In this study, the investigators aimed to analyse the cost-effectiveness of an intensive early-intervention programme, using data from First Episode Psychosis Clinical Program (PAFIP), the largest trial treating first episode non-affective psychosis in Spain to date.

NCT ID: NCT02532491 Enrolling by invitation - Schizophrenia Clinical Trials

Effectiveness of Second Generation Antipsychotics in First Episode Psychosis Patients: 1-year Follow-up

PAFIP3_1Y
Start date: May 2014
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT02487888 Enrolling by invitation - Pain Clinical Trials

A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care

REVOLUTION
Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of genetic testing on healthcare decisions and patient outcomes for patients suffering from pain, cardiovascular problems, Arthritis, Type II Diabetes, and/or Mental Health disorders. Results of genetic testing will also be compared with the clinical outcome measures collected to discover novel genetic factors that may influence patient care.

NCT ID: NCT02200588 Enrolling by invitation - Schizophrenia Clinical Trials

Longitudinal Long-term Study (10 Years) of the Sample of First Episode of Non-affective Psychosis: PAFIP

10PAFIP
Start date: September 2014
Phase:
Study type: Observational [Patient Registry]

Schizophrenia is a chronic brain disease that is still understood as a condition that limits the development of a normal life for the patient who suffers it and their families. The idea that only one third of patients have a good outcome is still in force, despite the lack of clinical and epidemiological longitudinal studies that have addressed this issue rigorously. Most studies that have established the poor prognosis of the disease have followed a cross-sectional design and are based on samples of patients undergoing treatment in healthcare devices and therefore represents an important bias. Based on clinical, cognitive, functional outcome and biomarkers studies (brain imaging) to medium term (3 years) we can establish that the particular idea of poor prognosis should be reconsidered. The development of longitudinal studies of first-episode patients in representative samples of a population and long-term it is of high value to shed light on the clinical course of the disease. The belief that there are factors determining the disease progression beyond the initial three years brings us to publish this study. Given this background, our project's main objective is to know the evolution at 10 years of patients followed in the First Episode Psychosis Clinical Program (PAFIP). Our hypothesis is that a higher percentage of expected patients have a favorable outcome of the disease. Factors such as enhancing treatment completion, abstinence from drug use, return to work, the reduction of expressed emotion in families during the early years of the disease (at least 3 years of intensive intervention PAFIP) will have a positive impact on the evolution of patients on long-term (10 years). Our hypothesis defends the existence of certain factors as independent risk factors for poor clinical and functional outcome of patients who should be known for establishing intervention strategies that attempt to mitigate their impact on the quality of life of patients and their families.

NCT ID: NCT02095938 Enrolling by invitation - Schizophrenia Clinical Trials

Association of Amisulpride Response in Schizophrenia With Brain Image

ARB
Start date: January 2014
Phase: Phase 4
Study type: Interventional

1. Study rationale - Nielsen et al reported that after 6 weeks of amisulpride treatment, patients with schizophrenia showed an increase in the anticipation-related functional MRI signal. This suggested that amisulpride could affect the brain structures and that responses to amisulpride could be associated by the brain structures as seen previous studies about treatment response to antipsychotics and brain structures. But to date, no study has examined the impact of brain structure alterations on amisulpride treatment for schizophrenia and its potential clinical significance. 2. Study Objectives 2-1. Primary: To show the differences of the baseline brain structures on the structural MRI between the Solian® treatment responders and the non-responders 2-2. Secondary: To show the differences of the baseline polymorphisms of COMT and BDNF with molecular genetic analysis between the Solian® treatment responders and the non-responders responder defined by PANSS. To find out the correlates of baseline brain structures with symptom severity of schizophrenia at baseline; symptom severity defined by CGI-S and PANSS. To assess psychotic symptom improvement after 8th week of Solian® treatment using PANSS, SANS, SAPS and CGI. To assess safety after 8th week of Solian® treatment with Barnes Akathisia Scale, Simpson-Angus scale and vital signs. To report all serious adverse event within 24hrs regardless of relationship to investigational product. 3. Study Design: Prospective/ Open label/ Interventional/ Controlled 4. Evaluation Criteria: 5-1. Primary endpoints: Brain structures on the structural MRI will be observed before the treatment starts. Based on the clinical response after treatment, patients will be divided in the two different groups as follow and their baseline brain structure of will be compared. Treatment responders and non-responders. 5-2. Secondary endpoints: The relationship of baseline brain structures with symptom severity of schizophrenia. Severity will be determined by CGI-S and PANSS at baseline. The differences of the polymorphisms of COMT and BDNF with molecular genetic analysis using patients' peripheral blood, especially leukocytes, between the treatment responders and the non-responders. Efficacy - PANSS, SANS, SAPS, CGI. Safety - Barnes akathisia scale, Simpson-Angus scale, Vital signs

NCT ID: NCT01831986 Enrolling by invitation - Schizophrenia Clinical Trials

Pregnenolone and L-theanine Augmentation in the Treatment for Schizophrenia and Schizoaffective Disorders

Start date: January 2011
Phase: N/A
Study type: Interventional

Schizophrenia (SZ) and schizoaffective (SA) disorders are comprised of several debilitating symptoms. It was suggested that compounds with neuroprotective effects might be useful in the management of SZ/SA symptoms. Our previous clinical trials indicated significant beneficial effects for augmentations with two different neuroprotective agents: Pregnenolone and L-Theanine. Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous system. Our recent 8-week, randomized, double-blind trial among patients with chronic SZ/SA disorders, in which PREG versus placebo and DHEA was added to antipsychotics, yielded encouraging results: PREG augmentation demonstrated significant amelioration of positive symptoms, EPS, as well as an improvement in attention, and working memory performance of SZ/SA disorder patients (Ritsner et al 2010). L-Theanine is a unique amino acid present almost exclusively in the tea plant. It possesses neuroprotective, mood-enhancing, and relaxation activities. L-theanine augmentation to antipsychotic therapy can ameliorate positive, activation, and anxiety symptoms in SZ/SA disorder patients (grant # 06TGF-911, (Ritsner et al 2010). This proposed study would extend our prior research with Pregnenolone and L-theanine by combining both agents versus placebo. We hypothesized that addition of both these compounds to ongoing antipsychotics would significantly improve the clinical status of SZ/SA patients. Methods: In an 8-week, randomized, double-blind placebo-controlled trial a combination of PREG (50 mg/day) with L-theanine (400 mg/day) versus placebo will be added to the stable ongoing antipsychotic treatment of 200 patients with schizophrenia or schizoaffective disorders. This trial will be conducted at five sites in Israel. Participants will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of research instruments will be used for the assessment of psychopathology, side effects, general functioning and quality of life

NCT ID: NCT01769014 Enrolling by invitation - Schizophrenia Clinical Trials

Adherence and Quality of Life in People With Schizophrenia and Schizoaffective Disorder

Start date: January 2013
Phase: N/A
Study type: Observational

It is the goal of this study adherence and quality of life in a population of people suffering from schizophrenia or schizoaffective disorder and to analyze if these factors are influenced by treatment, support, social services, and residential treatment. The study population is drawn from the the cantons Glarus and Graubunden as well as Liechtenstein.