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351 active trials for Schizophrenia

Minnesota Community-Based Cognitive Training in Early Psychosis

The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset psychosis who are being treated in community mental health settings using the NAVIGATE model. The investigators will examine the effects of web-based cognitive training exercises delivered on iPads. Participants will be randomized to one of three conditions, and will be assessed at Baseline, Post-Intervention, and 6 Month Follow Up on measures of clinical, neurocognitive, and functional status.

Start: May 2017

Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer

The purpose of this research is to understand if it is helpful for patients with mental illness to be connected to a psychiatrist and case manager at the time of cancer diagnosis.

Start: December 2017

A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia

This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis.

Start: October 2020

Do Antipsychotic Agents Induce Supersensitivity in Humans: A Combined PET/MRI Study in Patients With Schizophrenia

The aim of the present study is to detect changes in the dopamine system in the brain of patients with schizophrenia, especially when pretreated with antipsychotic medication. Here, the investigators want to find out whether the treatment with these drugs can cause permanent changes in docking points (receptors) of dopamine in the brain. It will be examined whether number and response of dopamine receptors is altered, which are associated with the onset of psychotic symptoms. For this purpose, a single PET/MR measurement will be performed in all participants. In total 140 volunteers, consisting of 30 healthy volunteers, 20 first-episode, drug-naive patients with schizophrenia and 90 pretreated patients with schizophrenia will be included over a time period of three years. In addition, the influence of nicotine consumption on dopamine receptors will be invesitgated by comparing data from smoking and non-smoking patients. In clinical practice, an elevation of dopamine action caused by alterations in receptors in the brain is of most importance. This may be the reason why the treatment with antipsychotic agents does not work in some patients. In addition, a permanent elevation of dopamine action is associated with permanent brain alterations by these drugs. The result can contribute to work out valuable indications, whether it makes sense to continue a long term therapy with antipsychotic drugs in a patient. But also the in-depth understanding of the impact of nicotine on the course of therapy can help to open up possibilities for improved drug treatment.

Start: August 2020

Enhancing Recovery in Early Schizophrenia

Current antipsychotic treatments of schizophrenia are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained.

Start: April 2017

Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness

Maintenance of employment is dependent upon being able to successfully integrate into one's work setting. This can present a significant challenge to individuals with serious mental illness, as they typically exhibit impairment in their ability to accurately perceive and understand social exchanges. Presently the most established intervention is Social Cognition and Interaction Training (SCIT), a 12-week group intervention in which participants learn strategies to enhance emotion recognition and to assess the accuracy of their interpretation of social interactions. To enhance transfer of training gains to functional outcomes, participants will be paired with a social mentor to facilitate completion of homework and to ensure that skills are practiced outside of treatment (supported SCIT). The study will examine the impact of supported SCIT on social and work role functioning. The specific aims are: To assess the feasibility of providing supported SCIT to individuals with serious mental illness who are engaged in compensated work activity. To assess the impact of supported SCIT on social cognitive skills as well as work and social performance. To assess durability of intervention-induced change 3 months after the end of intervention. A single blind study will be conducted in which 60 participants between 18-70 with serious mental illness (schizophrenia, schizoaffective disorder, and bipolar disorder) are assigned to 12 weeks of supported SCIT or an active placebo condition, a computer skills course. Each intervention will consist of two 1-hour small group training sessions and 1 hour of individualized supported practice of skills with a treatment facilitator weekly. Feasibility will be assessed with attendance at group and individual sessions. Baseline, post-intervention, and follow-up assessments will measure social cognitive abilities and functional outcomes . Potentially confounding variables such as symptom severity and outside treatment hours will also be assessed. It is hypothesized that supported SCIT will be completed by at least 75% of veterans assigned to that condition. The intervention is predicted to improve social cognitive skills and social and work performance. Training gains are expected to be sustained 3 months after intervention.

Start: January 2016

Treatment of Cognitive and Negative Symptoms in Schizophrenia With N-acetylcysteine

The purpose of this study is to attempt to treat cognitive and negative symptoms of schizophrenia, with the nutritional supplement N-acetylcysteine (NAC). Schizophrenia is a chronic mental disorder that affects approximately 65 million people worldwide, and causes significant disability and suffering. Patients with schizophrenia often hear voices and have persecutory delusions. Though these are the most recognizable features of the illness, the deficits most closely linked to disability are known as cognitive deficits and negative symptoms. Cognitive abilities refer to the ability to perform mental tasks that require focus and attention, and also include memory and verbal skills. Negative symptoms refer to a lack of interest in the world, and decreased social interactions. In our study, the investigators aim to improve these symptoms and deficits by targeting the glutamate system. Glutamate is the major excitatory neurotransmitter in the brain, and its regulation is abnormal in schizophrenia: glutamate levels are too low at some receptors, and too high at others. As well, free radicals surrounding glutamate receptors also interfere with their proper function. N-acetylcystine (NAC) is a safe and widely-available dietary supplement that may restore glutamate to its correct levels in the brain, and may also help protect the brain from antioxidant damage. In our study, patients with schizophrenia will be randomly assigned to receive either NAC or placebo for 8 weeks. Brain levels of glutamate and an important antioxidant, glutathione, will be measured before and after treatment, using a neuroimaging technique known as magnetic resonance spectroscopy. Cognitive and negative symptoms will also be assessed before, during and after treatment. The investigators hypothesize that glutamate and glutathione will be normalized in patients' brains, and that their negative and cognitive symptoms will be improved, too.

Start: February 2017

Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.

Start: February 2021

Clinical Risk State for Bipolar Disorder in Adolescents

Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors of the disease development. Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of Bipolar Disorder (BPD) or schizophrenia. Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will differentiate between individuals developing BPD and schizophrenia.

Start: September 2009

Ketogenic Diet for Psychotic Disorders

Disturbances in glucose metabolism and glutamate neurotransmission feature in the pathophysiology of psychotic disorders. Ketogenic diet (KD) is a high-fat, low-carbohydrate diet that restricts glucose and forces metabolism of ketones, which serve as alternative energy substrates for the brain. KD is an established treatment for intractable epilepsy. However, we lack the randomized controlled trials (RCT) evidence regarding potential effects of KD on psychotic symptoms in humans. This randomised, controlled pilot study aims to investigate: feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients, potential impact of MKD intervention on psychotic symptoms, depressive and anxiety symptoms, and functioning in patients with psychotic symptoms / psychotic disorder. A 6-week randomised KD pilot study will be carried out in psychotic inpatients (aimed n=40) at Kuopio University Hospital, Finland. In the KD group, carbohydrate consumption is limited to 15-20 g/day to activate ketosis. The control group will have their ordinary hospital meals. A number of different assessment will be carried out at time points 0, 1 week, 3 weeks and 6 weeks.

Start: March 2021

Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment

This study will be conducted to evaluate the efficacy, safety, and tolerability of GWP42003-P versus placebo in participants with schizophrenia experiencing inadequate response to ongoing antipsychotic treatment.

Start: August 2020

Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia

Social cognition is an individual's ability to perceive, process, understand, and react to other individuals in a social situation. Social cognition is impaired in individuals with schizophrenia, including difficulty recognizing others' emotions. A promising treatment avenue for emotion recognition problems in individuals with schizophrenia is continued practice with various facial expression recognition training programs. First degree relatives of someone with schizophrenia are considered at familial high risk (FHR) for the illness, because of its high level of heritability. It is therefore critical to explore if these emotion recognition training programs could also benefit people at FHR. In this current study, the investigators aim to explore the social-cognitive profiles and their neural correlates in FHR individuals. The investigators also aim to explore the potential efficacy of an emotion recognition intervention to improve this ability in FHR individuals.

Start: February 2021

A Neurofeedback Intervention to Improve Working Memory in Schizophrenia

Schizophrenia affects 2.4 million Americans and causes significant individual and societal costs. Cognitive deficits including poor working memory arise early in the course of illness, account for poor long-term outcomes and have been difficult to treat with available treatments. The investigators are proposing to develop a novel, computer-based brain training to improve working memory in schizophrenia patients, which, if successful could have significant personal, societal, and economic impact.

Start: March 2018

Cognitive Processes In Psychosis

This study will recruit schizophrenia patients who use cannabis recreationally. Each participant will attend the laboratory on three occasions: an initial visit to check that they are safe to join the study, and three days of testing. Across the three testing days participants will, in a randomized order, be administered CBD orally and then inhale cannabis containing THC, a oral placebo and then inhale cannabis containing THC, and an oral placebo and inhale placebo cannabis. The THC administration will follow a standardised inhalation procedure using a medical-grade vaporizer device. Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences. The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.

Start: January 2021

Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis

The purpose of this study is to better understand mental illness and will test the hypotheses that while viewing affective stimuli, patient groups will show increased blood oxygenation level dependent (BOLD) signal by fMRI after lorazepam. This study will enroll participants between the ages of 16 and 60, who have a psychotic illness (such as schizophrenia, bipolar disorder, and schizoaffective disorder). The study will also enroll eligible participants without any psychiatric illness, to compare their brains. The study will require participants to have 3-4 sessions over a few weeks. The first session (may be over two visits) will include a diagnostic interview and several questionnaires (qols) to assess eligibility. Subsequently, there will will be two separate functional magnetic resonance imaging (fMRI) sessions in which lorazepam or placebo will be given prior to the MRI. During the fMRI the participants will also be asked to answer questions. Additionally, the participants will have their blood drawn, women of child bearing potential will have a urine pregnancy test, vital signs taken, and asked to complete more qols.

Start: January 2020

Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age

The primary objective of the study aims to study transition toward schizophrenia in patients with learning disorders, and to compare the risk between patients with specific learning disorders, and patients with complexed learning disorders (by two types: patients with other neuro-developmental disorders including executive function disorders, and patients with anxiety).

Start: January 2020

Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Schizophrenia or Bipolar Illness

To initiate a low-carbohydrate, high-fat (LCHF) ketogenic dietary intervention among a small cohort of outpatients with either schizophrenia or bipolar illness and comorbid overweight/obesity currently taking psychotropic medications. Adults with mental illness represent a high-risk, marginalized group in the current obesity epidemic. Among US adults with severe mental illness, obesity and overweight are highly prevalent conditions having severe consequences, with patients estimated to die on average 25 years earlier than the general population largely of premature cardiovascular disease. In addition, many psychiatric medications, particularly antipsychotics and mood stabilizers, can contribute to metabolic side effects and weight gain. Low-carbohydrate high-fat (LCHF) diets have been shown to reduce cardiovascular risk in those with insulin resistance. The purpose of this study is to evaluate both the metabolic and psychiatric outcomes with an LCHF diet in this psychiatric population.

Start: February 2019

Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.

Start: December 2019

Adjunctive Vortioxetine in Schizophrenia

This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88 stable patients with a research diagnosis of schizophrenia determined with the Structured Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining whether earlier illness moderates greater negative and /or cognitive symptom reduction in response to vortioxetine.

Start: February 2016

Rituximab Treatment for Psychosis and/or Obsessive Compulsive Disorder With Probable Immune System Involvement

The primary objective for this study is to evaluate whether Rituximab as compared to placebo is a clinically effective treatment for a subgroup of patients suffering from psychosis and/or obsessive-compulsive disorder (OCD) or -behavior (OCB) where there is an indication of immune system involvement. The secondary objectives of this study are To assess whether Rituximab treatment (with the doses and timing described below) as compared to placebo is associated with amelioration in psychiatric symptomatology To assess whether Rituximab treatment as compared to placebo is associated with improvement in executive functions To assess whether Rituximab treatment as compared to placebo is associated with amelioration in neurological symptoms To evaluate the longevity of psychiatric, neurological and executive improvements associated with Rituximab treatment for up to 16 months after the first infusion (i.e. 12 months after the last infusion) To evaluate whether Rituximab treatment as described is safe for these patients. The exploratory objectives of this study are To assess changes in blood and cerebrospinal fluid (CSF) markers for immune activity associated with Rituximab treatment compared to placebo To assess statistical associations between biological markers in blood or CSF and clinical response To describe changes in somatic symptoms associated with treatment with Rituximab vs placebo for patients with initial symptoms in the questionnaires To describe changes on MR and EEG associated with treatment with Rituximab vs placebo for patients with initial pathology in these examination To study immune mechanisms coupled with psychiatric symptoms, possibly identifying novel biomarkers with potential for subtyping encephalopathies with immune engagement, using biobank cells, blood and CSF samples collected from the participants.

Start: August 2021