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Schizophrenia clinical trials

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NCT ID: NCT03576911 Active, not recruiting - Schizophrenia Clinical Trials

A Randomised Controlled Trial of Coenzyme Q10 in Patients With Schizophrenia and Schizoaffective Disorder

Start date: November 2016
Phase: N/A
Study type: Interventional

The study is a randomised placebo controlled trial of Coenzyme Q10 (CoQ10) vitamin supplementation in a sample of patients with schizophrenia or schizoaffective disorder. CoQ10 is produced in the mitochondria of our cells, and is involved in the production of energy. However, some people do not produce enough CoQ10, which can result in difficulties with concentration and memory, depressive symptoms, low energy levels and high blood pressure. The study will examine the impact of taking oral CoQ10 supplementation on patients with schizophrenia and schizoaffective disorder.

NCT ID: NCT03575442 Active, not recruiting - Schizophrenia Clinical Trials

"Art Therapy" in Acute Psychiatry

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Background: Given the complexity of this problem, psychiatric in-patients in the acute stage of their disease need different types of therapeutic programs to recover they mental health state. Usually they're submitted to systematic biological programs (namely psychopharmaceuticals), often considered a priority when compared to psychosocial programs. Among the different therapies that have been introduced in this context "art therapy", also named creative therapy, can constitute a treatment that complements the allopathic treatments, providing improvements in self-esteem and self-efficiency, distraction and relief from concerns and negative thoughts. Scientific evidence on the effects of psychosocial programs in the context of hospitalization of acute cases is scarce. Aims: a) evaluate the effectiveness of a 3 session program of "art therapy" in changing emotional indicators, namely depression, anxiety, stress, and psychological well-being, in individuals with mental illness; b) analyze the meanings a person attributes to his creative self-expression. Method: This is a pre-experimental, prospective study, with a pre test-post test design without control group, with a mixed approach (quantitative and qualitative). The study was performed in the psychiatry unit (Psiquiatria B), in the Centro Hospitalar e Universitário de Coimbra - Portugal. The target population was composed by men (older than 18), hospitalized in this ward. The exclusion criteria were: individuals with active psychotic symptomology, in manic phase and/or refusing to participate. The instruments used to collect information were: Depression, Anxiety and Stress Scale [DASS-21]; Ryff Scales of Psychological Well-Being (SPWB - 18 item version) and a semi-structured interview. Data collection and the development of this study occurred in the following manner: - Initial evaluation to verify the sample selection criteria in the first 48 hours after patient hospitalization; - Obtain informed consent for the application of instruments and participation in the "art therapy" intervention program; - Application of instruments (DASS-21 and SPWB-18 item version) before intervention; - Development of the program applied as a group, during three weeks, one session a week, each lasting approximately 90 minutes and assisted by a specialist in plastic expression. Each session was held in an occupational therapy room, including all the material deemed necessary for the execution of some of the techniques introduced by the technician. After each session, a semi-structured interview was conducted with each participant in order to analyze the meanings attributed. - In the end of the program, the same instruments were reapplied.

NCT ID: NCT03575000 Not yet recruiting - Schizophrenia Clinical Trials

Bromocriptine for Patients With Schizophrenia and Prediabetes

Start date: July 1, 2024
Phase: Phase 4
Study type: Interventional

This is a multicenter open-label, pilot study to evaluate the safety and tolerability of bromocriptine, a dopamine D2/D3 receptor and serotonin 5-HT2C receptor agonist, as an adjunct to preexisting standard-of-care antipsychotic drug (APD) regimens in the management of APD-associated impaired glucose tolerance (IGT)/insulin resistance (IR). The ultimate aim of the study team is to evaluate the efficacy of bromocriptine in treating the metabolic disturbances associated with APDs and the hypothesis is that bromocriptine will be a well-tolerated, safe, and inexpensive way to ameliorate these metabolic complications and prevent or delay the onset of type 2 diabetes (T2D). This study will be a small, short-duration pilot focusing on safety and tolerability. A total of 15 psychiatrically stable APD-treated adult outpatients, VA Pittsburgh , aged 18 to 65 years old, with a confirmed diagnosis of schizophrenia and comorbid IGT will be recruited and receive 6 weeks of bromocriptine (flexibly titrated, 2.5-5.0 mg PO daily). Key inclusion criteria are: 1) currently being treated with second generation APDs for 3 or more months with no change in dose in the 1 month prior to enrollment, 2) fasting glucose 100 to 125mg/dL and/or hemoglobin A1c (HbA1c) 5.7-6.4%. Key exclusions are: 1) prior APD nonadherence, 2) drug/alcohol abuse in the 3 months prior to screening, 3) a history of violent behavior/psychoses, 4) pregnancy, or 5) a diagnosis of diabetes. Subjects on other dopamine agonists or on medications that may interact with bromocriptine and those taking corticosteroids or other medications that may alter glucose levels will be excluded. The purposes of the study are to demonstrate safety/tolerability, demonstrate feasibility, provide proof of concept, and provide an open-label assessment of the metabolic and psychiatric effects of bromocriptine in patients with schizophrenia treated with APDs. The primary metabolic outcome measures will be change in IR as measured by the HOMA-IR and change in IGT measured by HbA1c. Secondary metabolic outcome measures include body weight, fasting lipids, and prolactin. The specific aims are as follows: Specific aim 1: To establish the safety and tolerability of bromocriptine in patients with schizophrenia and IGT/IR treated with APDs. Specific aim 2: To demonstrate feasibility/proof of concept for an improvement in APD-induced IGT/IR with bromocriptine.

NCT ID: NCT03571685 Completed - Schizophrenia Clinical Trials

Sustainable Early Episode Clinic Study (SEEC)

SEEC
Start date: January 31, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to describe relapse rates among participants receiving services in the SEEC program high intensity resource use. For purposes of this study, relapse will be defined as: Psychiatric hospitalization; Psychiatric emergency department visits; Ambulatory acute services (Partial Hospitalization Program, Intensive Outpatient Program, Crisis House stay).

NCT ID: NCT03568500 Completed - Schizophrenia Clinical Trials

A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic

Start date: May 21, 2018
Phase: Phase 4
Study type: Interventional

Digital medicine systems (DMS) have been designed to assist individuals with the management of their daily health, wellness, and medication use. The DMS is being developed as a healthcare management tool to precisely measure medication adherence and to potentially enhance adherence.

NCT ID: NCT03565068 Completed - Schizophrenia Clinical Trials

A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)

MDCS
Start date: June 20, 2018
Phase: Phase 1
Study type: Interventional

This 4-panel study will evaluate the safety, tolerability, pharmacokinetics (PK) and corrected QT interval (QTc) effect of MK-8189 versus placebo, as monotherapy in healthy participants (Panel A) including those of Japanese descent, as monotherapy in participants with schizophrenia (Panel B), as add-on therapy in participants with schizophrenia (Panel C), and under an alternative dosing regimen as monotherapy in participants with schizophrenia (Panel D). Analysis of QTc effect will be exploratory. There will be no hypothesis testing in this study.

NCT ID: NCT03559426 Completed - Schizophrenia Clinical Trials

Research Into Antipsychotic Discontinuation and Reduction Trial

Start date: March 24, 2016
Phase: Phase 4
Study type: Interventional

Psychosis and schizophrenia are common and costly mental health problems. Psychosis is the name given to a group of mental conditions in which cause people to perceive or interpret things differently from those around them. One of the most common causes of psychosis is schizophrenia, a condition that causes a range of psychological symptoms, including hallucinations (hearing and/or seeing things) and delusions (believing something that is not true). One of the main treatment options for psychosis and schizophrenia is long-term treatment with antipsychotic medication, but many patients still find life difficult. Antipsychotic drugs can also have dangerous and unpleasant side effects. Finding alternatives to long-term drug treatment is a priority for patients and services. This study is testing the effects of gradually reducing antipsychotic medication in people with schizophrenia, psychosis or similar conditions in order to see if it can help improve day-to-day functioning and how it affects their chance of suffering a relapse (worsening of their condition).

NCT ID: NCT03558529 Completed - Schizophrenia Clinical Trials

Feasibility and Acceptability of a Smartphone App to Assess Early Warning Signs of Psychosis Relapse

ExPRESS:2
Start date: May 1, 2015
Phase:
Study type: Observational

About 1 in 100 people will experience an episode of psychosis. Some people will only experience one 'psychotic episode' and about a quarter of people make a full recovery. Others will have recurring periods of problems ('relapses'), perhaps at times of particular stress. As people often find psychosis distressing, this study looks at ways to help them stay well in the future. There is growing evidence that 'early signs' interventions can prevent relapses of psychosis. Early signs are things that might happen when people start to become unwell. For example some people start to sleep badly when they are becoming unwell. Most people with psychosis can identify early signs emerging in the weeks before relapse. In early signs interventions, service users are taught to recognise early signs that their mental health may be deteriorating so that they can take action to avoid becoming unwell. Although early signs interventions show promise, the investigators suggest that they can be improved by more accurate assessment of relapse risk. This might be achieved by monitoring 'basic symptoms' in addition to conventional early signs of relapse. Basic symptoms are subtle, subclinical disturbances in one's experience of oneself and the world. Typical basic symptoms include: changes in perceptions, such as increased vividness of colour visionÍž impaired tolerance to certain stressorsÍž difficulty finding or understanding common words. In this study the investigators want to design and test a mobile phone app to help monitor basic symptoms. They hope that the app might help service users to stay well in the future. During the study the investigators will ask participants to use the app once a week for 6 months. At the end of the study they will interview them about their experiences of using the phone app and participating in the study.

NCT ID: NCT03557931 Completed - Schizophrenia Clinical Trials

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

Start date: July 13, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand used a Hypothetical Strategy and compared participants as though the participant had continued on the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to placebo. This study also evaluated the effects of ASP4345 compared to placebo on functional capacity using the University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) total score and evaluated the pharmacokinetic profile of ASP4345.

NCT ID: NCT03554655 Completed - Clinical trials for Schizophrenia, Schizotypal and Delusional Disorders

The Efficacy of Using a Smartphone App to Support Shared Decision Making in People With a Diagnosis of Schizophrenia

Start date: January 7, 2019
Phase: N/A
Study type: Interventional

This study investigates the effects of using a smartphone app to support shared decision making (SDM) for people with schizophrenia-spectrum disorders in an outpatient treatment setting. Patients are randomized to specialized early intervention treatment with the Momentum app or without the app. The primary objective is to investigate the effect of the app on patient activation 6 months after baseline. Secondary outcomes are positive and negative symptoms, level of functioning; working alliance; self-efficacy; treatment satisfaction; hope; level of SDM; and perceived efficacy in patient-provider interaction. Explorative outcomes are self-perceived usefulness of the Momentum app.