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351 active trials for Schizophrenia

Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia

The purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia

Start: March 2021

Assessment and Treatment for Chronic Pain in Veterans With Serious Mental Illness

Chronic pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic pain leads to poorer mental health and physical functioning, and represents a critical obstacle to rehabilitation and recovery. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to: a) evaluate nonpharmacological pain management strategies in this population, and b) examine directional relations between chronic pain and SMI symptoms. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI, and b) better assessing the complex relation between chronic pain and psychiatric symptoms and their impact on functioning. Results from this study will inform us as to whether CBT-CP is feasible to implement, acceptable to Veterans with SMI, and worth examining in its standard or in an optimized form in a larger clinical trial.

Start: March 2021

The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

This is a single center study that uses both between-group comparisons and correlational analyses to establish biomarkers of dysmyelination and cognitive impairment in Psychotic Spectrum Disorders using imaging and neuropsychological assays.The study will provide non-invasive biomarkers of cognitive dysfunction in Psychotic Spectrum Disorder.

Start: July 2016

In-person vs. Remote Wellness Support

The study team will use components of the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to compare Cognitive Adaptation Training (CAT) to Remotely delivered Cognitive Adaptation Training (R-CAT) 1-9 within a managed care organization (MCO), targeting members with serious mental illness (SMI) needing assistance with the regular taking of medication.

Start: November 2020

Medial-prefrontal Enhancement During Schizophrenia Systems Imaging

This randomized controlled trial in healthy controls (HC) and patients with schizophrenia (SZ) aims to examine 1) the underlying cognitive and neural cause of self-agency deficits in SZ; 2) the responsiveness to a novel navigated repetitive transcranial magnetic stimulation (nrTMS) target in the medial prefrontal cortex (mPFC); and 3) how modulation of mPFC activity impacts the larger self-agency network to mediate changes in self-agency judgments. Our overall hypothesis is that increased mPFC excitability by active high-frequency nrTMS in HC and SZ will induce behavioral improvements in self-agency and neural changes in the larger self-agency network that will generalize to improvements in overall cognition, symptoms and daily functioning, and will likely lead to the development of new effective neuromodulation therapies in patients with schizophrenia.

Start: November 2020

A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia

Schizophrenia has a devastating and disproportionate effect on veterans compared to the general US population. Some of the most disabling symptoms, such as low motivation, difficulty expressing emotions, and decreased ability to infer the mental states of others, cause poor social functioning. This means that veterans with schizophrenia have trouble navigating interpersonal interactions and building meaningful relationships in the community. Unfortunately, current antipsychotic medications typically only improve positive symptoms but fail to improve social functioning deficits, which are strong predictors of poor quality of life and functional outcomes. Oxytocin, a peptide found in the brain, plays an important role in social behavior and is known to moderate affiliation, stress, and learning across taxa. In this study, the investigators will test whether oxytocin could be an effective treatment for social functioning deficits in schizophrenia. The investigators will examine changes in brain activation to understand how oxytocin affects behavior and to predict which individuals may benefit from oxytocin treatment.

Start: January 2020

Models of Auditory Hallucination

The purpose of this study is to address the shortcoming in clinical hallucination research by causally manipulating the neural loci of conditioned hallucination task behavior in-person in patients with psychosis using transcranial magnetic stimulation (TMS), tracking the impact of this manipulation on the number of times participants with hallucinations report hearing tones that were not presented. With such a causal intervention, the veracity of this explanation of hallucinations will be either validated or disconfirmed. If validated, the task can be further developed as a biomarker for predicting the hallucination onset, guiding, developing or tracking the effects of treatments for hallucinations.

Start: February 2020

The Effects of Three Different Modalities of Exercise in Patients With Schizophrenia

Exercise has been shown to improve health in patients with schizophrenia. However, it remains unclear which modality of exercise reports better benefits. Aim: To compare the effects of different modalities of exercise training on psychological and physiological variables in schizophrenia.

Start: January 2020

fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

The INTRUDE trial aims at assessing the efficacy of an fMRI-based neurofeedback procedure on drug-resistant auditory hallucinations. Hallucinations are complex and transient mental states associated with subtle and brain-wide patterns of activity for which we were recently able to validate an fMRI multivariate decoder. Based on this progress, we can track patients' hallucinatory status using real-time fMRI. We will test whether schizophrenia patients with drug-resistant hallucinations can be trained to maintain the brain state associated with a no-hallucination condition using appropriate strategies and thus reduce overall severity. We will refer to a double-blind randomized placebo-controlled design. A total of 86 patients will be enrolled and equally split in an active neurofeedback group (n=43) and a sham group (n=43), matched for sex, age and PANSS scores. Each patient will benefit from 4 runs of either active or sham neurofeedback. The primary outcome measure will be the mean decrease of AHRS scores relative to baseline, and at 1 month post-treatment. We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group.

Start: April 2021

PCORI Integrated Care (IC) Models for Patient-Centered Outcomes

Multiple chronic conditions (MCC) are widely recognized as the U.S. public health challenge of the 21st century. These physical and behavioral health conditions take a large toll on those suffering from the diseases, including many who are publicly insured, as well as caregivers and society. While evidence-based integrated care models can improve outcomes for individuals with MCC, such models have not yet been widely implemented. Insurance providers/payers have innovative system features that can be used to deploy these models; however, the investigators do not yet know which of these features can best help to improve outcomes for individuals with MCC in general or high-need subgroups in particular. As a result, patients lack information to make important decisions about their health and health care, and system-level decision makers face ongoing challenges in effectively and efficiently supporting those with MCC. This real-world study will provide useful information about available options for supporting individuals with MCC. Building on existing integrated care efforts, the investigators will enroll N=1,927 (N=265 Phase I and N=1,662 Phase II) adults with MCC at risk for repeated hospitalizations and assess the impact of three payer-led options (e.g. High-Touch, High-Tech, Usual Care) on patient-centered outcomes, namely patient activation in health care, health status, and subsequent re-hospitalization. The investigators will also determine which option works best for whom under what circumstances by gathering information directly from individuals with MCC through self-report questionnaires, health care use data, and interviews.

Start: April 2018

Virtual Reality Avatar Therapy for People Hearing Voices

Hearing voices is probably the worst form of acoustic hallucinations; which can be experienced as severely disturbing and is influenced by diverse factors including the ability of the individual to influence and control the hallucinatory experience itself. In recent years virtual reality has become a treatment option. In the so-called AVATAR Therapy, patients with schizophrenia and acoustic hallucinations design a visual and auditory recreation (avatar) of the entity to which they attribute their hallucinations. Working with a therapist over the course of several sessions, participants change the avatar from controlling to benevolent. Avatar Therapy involves similar processes to learning and cognitive restructuring, comparable to other psychotherapeutic interventions. The investigators plan to conduct an interventional study using a cross-over design, to compare the feasibility and efficacy of virtual reality avatar therapy for patients with acoustic hallucinations (independent of psychiatric diagnosis) with a cognitive behavioural group therapy aimed to improve social competence.

Start: April 2021

Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.

Start: March 2021

Carnosine and Cognitive Training in Schizophrenia

This is a double-blind placebo-controlled trial to evaluate the effects of the combination of a cognition enhancing drug, i.e carnosine, with cognitive training in patients with schizophrenia. All participants will receive the same cognitive training sessions and will be randomised to either carnosine or placebo for the duration of the combined treatment period (2 weeks). Before combined training and carnosine/placebo, there is a two-week carnosine/placebo only phase to examine the effects of carnosine alone on functioning without training.

Start: December 2015

OnTrack>An Online Role-Playing Game for Young People With First Episode Psychosis

The research team will develop and test a prototype version of OnTrack>An Online Role-Playing Game (OnTrack>The Game or OTG), an online role-playing game designed for youth and young adults experiencing First Episode Psychosis (FEP). Phase I showed positive changes in quantitative measures of hope and recovery, as well as an enthusiastic response to the prototype as evidenced by qualitative interviews. In Phase II, the research team will refine, expand and finalize OTG and evaluate the effectiveness of OTG.

Start: November 2018

Academic-Community EPINET (AC-EPINET)

The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial.

Start: March 2021

Community-based Mental Health Care for People With Severe and Enduring Mental III Health

A single-blinded hybrid effectiveness-implementation trial (Type II), that both evaluates the intervention outcomes (clinical and service use outcomes) through patient-randomization in the implementation sites, as well as evaluates the implementation strategy chosen for the intervention and its impact on implementation outcomes (e.g. adoption, fidelity, acceptability and maintenance (continued implementation) of the intervention).

Start: January 2018

Alpha-lipoic Acid Adjunctive Therapy in Schizophrenia

Schizophrenia is a devastating mental disorder with a prevalence of approximately 1% worldwide. While effective in reducing positive symptoms, current treatments have limited effects on cognitive and social cognition/processing deficits of schizophrenia, which are closely linked to real-world dysfunction and lack of socio-occupational integration. There is compelling evidence for impaired antioxidant defense system and inflammatory abnormalities in schizophrenia. A new therapeutic approach to the disease might well be to hinder oxidative damage, inflammation and its clinical sequelae. Alpha-lipoic acid (ALA) is a naturally occurring compound, synthesized in the mitochondria, that is currently approved to treat diabetic neuropathic pain. Drug repurposing is a fast, and cost-effective method that can overcome drug discovery challenges of targeting neuropsychiatric disorders. In a pilot investigation, adjunctive treatment with ALA led to robust improvement in negative and cognitive symptoms of ten patients with schizophrenia. This project aims to investigate the efficacy of ALA as a disease-modifying drug for the treatment of schizophrenia, by improving sociability and cognition, as well as to correlate patients' response with biomarkers that will shed light on the pathophysiology of this complex disease. It comprises 1) a prospective, randomized, double-blind, placebo-controlled trial to evaluate efficacy of ALA to treat cognitive and negative symptoms of patients with schizophrenia and 2) an investigation of changes in biomarkers of oxidative stress in response to adjunctive treatment with ALA. The proposed study could establish a new adjunctive treatment for schizophrenia, recognize a novel pharmacological approach and help unveil the biological basis of the disease.

Start: September 2019

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Schizophrenia Patients With Auditory Hallucinations

To investigate the treatment effect of continuous transcranial magnetic stimulation on schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by functional MRI

Start: May 2016

Virtual Cognitive Behavioural Therapy for Psychosis

Participants with schizophrenia-spectrum disorders who are experiencing active symptoms of psychosis will randomized to either receive 6 months of individual cognitive behavioural therapy for psychosis or to receive treatment as usual. Participants will be assessed at baseline, 6 months, and 12 months.

Start: February 2021

Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?

In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them.

Start: July 2014