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351 active trials for Schizophrenia

French Source-monitoring Task

Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols. The aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.

Start: February 2020

Validation of a Clinical Screening Grid for Syndromic Schizophrenia

Background: Nowadays, despite a large number of studies about schizophrenia and genetics, clinical red flags for syndromic forms of schizophrenia remain poorly documented.

Start: July 2016

Using mHealth to Optimize Pharmacotherapy Regimens

This project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team members with clinically relevant and time-sensitive information that will inform and promote shared decision making (SDM) and personalized interventions. The result will be a time-sensitive, data-driven, collaborative process to optimize medication regimens in order to maximize benefits, minimize harms, and promote adherence.

Start: October 2020

RC2S+: Remediation of Social Cognitive Impairments

Background: Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. According to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional style; and (4 and 5) social perception and knowledge. The components of social cognition appear to be related to both symptomatology and functioning in everyday life. New strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. Overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes. The RC2S therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.

Start: November 2016

Target Engagement and Response to Oxytocin

This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.

Start: January 2018

Monotherapy of an NMDA Enhancer for Schizophrenia

Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing clinical symptoms and cognitive deficits and revealed favorable safety in patients with chronic schizophrenia. Of note, a substantial portion of schizophrenia patients refuse or cannot tolerate antipsychotics due to poor response or severe side effects. Therefore, this study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) as a monotherapy for the treatment of schizophrenia.

Start: January 2018

A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study.

A 12-Month Observational Prospective Multicentre Cohort Study based on existing and newly collected data of schizophrenia patients followed-up for one year in secondary care settings (psychiatric services). Schizophrenia patients will be enrolled in a consecutive manner over a period of 6 month into two cohorts according to their prescribing switching treatment: to lurasidone (cohort A) and to another SGA (cohort B).

Start: December 2020

Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers

This is an open label study in 4 cohort of 4 healthy volunteers each designed to evaluate the dopamine receptor occupancy of LB-102 at various doses and timepoints.

Start: January 2021

Improving Accessibility and Personalization of CR for Schizophrenia

This project will explore adaptations of treatments for schizophrenia, with the goal of optimizing their effectiveness in real-world clinical settings and readiness for broad deployment. Schizophrenia is associated with cognitive deficits that negatively impact essential areas of daily functioning. NY State Office of Mental Health (OMH) is the first and largest state system of care to implement a statewide program of cognitive remediation (CR), an evidence-based practice for improving cognition and aiding functional recovery. Through Cognitive Remediation to Promote Recovery (CR2PR), CR is now offered in outpatient programs, with plans to expand to more services and further adapt implementation to improve treatment outcomes. This project will work directly with OMH clinics and clinicians to build upon and improve current CR delivery methods. This project will study the impact of two adaptations. One focuses on increasing the accessibility of the program, which participants report is limited by the requirement of twice weekly attendance. This project will compare the feasibility and acceptability of delivering CR in either two clinic-based sessions (Clinic) or one clinic and one remote session (Hybrid) per week. Qualitative interviews will be conducted with stakeholders to explore the impact of the adaptation. The second adaptation is intended to improve personalization of CR by systematically accounting for individual differences in neurocognitive needs. Drawing upon convergent evidence for tailoring CR based on need for early auditory processing (EAP) training, this project examines whether integrating a measure of EAP into the current baseline assessment facilitates personalization of the menu of restorative computer-based exercises used in CR. Feasibility parameters and qualitative/quantitative data analyses of facilitators and barriers to Hybrid CR delivery will together inform further treatment refinement and the design of a larger effectiveness trial of Clinic versus Hybrid CR. This project will examine how EAP assessment is employed by practitioners to personalize the CR treatment plan and examine if EAP improvement is associated with cognitive outcomes in public practice CR settings. Finally cognitive, functional, and service use outcomes in Hybrid versus Clinic CR will be compared.

Start: July 2018

RELATE - Efficacy and Feasibility of a Cognitive Behavioural Module for Distressing Auditory Verbal Hallucinations

Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show some promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH through the use of experiential role-plays. A single centre pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but independent multicentre studies are required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial set up to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities.

Start: October 2020

Peer-led Psycho-education for Schizophrenia

Profession-led psycho-education programs for people with schizophrenia are evidenced to improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless, other benefits to patients, for example, their functioning and insight into illness or to be substantive in a longer term (>12 months) are inconsistent and uncertain, especially in Asian populations. This single-blind multi-site randomized clinical trial was to test the effects of a peer-expert-led psycho-education group intervention (in addition to usual care) for adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison to a profession-led psycho-education group or treatment-as-usual only.

Start: September 2020

Trial of Stimulus-response Potentiation in Schizophrenia

This clinical trial aims at examining the effects of auditory high-frequency stimulation in schizophrenia patient, aiming to increase their AEPs, which are known to be attenuated from previous literature

Start: September 2019

Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing

The primary aim of this study is to provide confirmation that Cognitive Remediation (CR) for schizophrenia, when personalized based on pre-treatment assessment of early auditory processing ability, facilitates improved cognitive and functional outcomes. Additional aims of this study address the mechanisms of treatment effect. The study uses a repeated-measures randomized trial design. Enrollment will be by invitation, open to individuals receiving services at select community behavioral health facilities where CR is offered. Clients who are eligible for the service, who agree to participate in research and who meet inclusion/exclusion criteria will be assessed on outcome measures and categorized via performance on the Tone Matching (TM) test, as EAP impaired (EAP-) or EAP intact (EAP+). Subsequently, EAP- and EAP+ subgroups will be randomized to either (1) Brain Basics (BB; n = 100), an EAP-enhanced CR approach or (2) Brain Training (BT; n = 100), a routine CR approach. Participants will be invited to participate in a second pre-treatment assessment to measure electrophysiologic responses to auditory stimuli. All participants will be scheduled to repeat outcome measure assessments after treatment and after a follow-up period. The EAP- group receiving BB will be invited to repeat electrophysiological paradigms post-treatment to investigate mechanisms of change related to the CR intervention. Verbal learning will be the primary outcome with functional capacity the secondary outcome. EEG is exploratory and will examine neurophysiologic markers of need for and response to EAP training.

Start: December 2020

Telmisartan Pilot Study on Treatment Resistant Schizophrenia

This study is a 4-week pilot study for subjects with Schizophrenia or Schizoaffective Disorder who have not experienced a significant relief of symptoms from current anti-psychotic medication. The Investigators hypothesize that 4 weeks of telmisartan at 80mg daily will alter glutamate and GABA in the brain as measured with 1H-Magnetic Resonance Spectroscopy (MRS) after 4 weeks treatment.

Start: February 2019

A 12-weeks Study to Evaluate the Dietary Fiber and Probiotics Treatment in Prevention and Intervention of Weight-gain and Cognitive Impairment of Schizophrenia or Bipolar Disorder

In this study, the investigators will evaluate the efficacy, safety and related mechanism of dietary fiber and probiotics alone and in combination as a add-on treatment in improving the antipsychotic induced weight gain, the cognitive impairment, and psychotic syndrome in schizophrenia or bipolar disorder patients. The study will recruit 100 schizophrenia or bipolar disorder patients who meet the criteria of DSM-5, and then randomized to 4 groups: probiotics group(PB group) dietary fiber group(FB group) probiotics plus dietary fiber group(PF group) and control group(CT group) for a 12-weeks clinical trail. The specific aims are to compare probiotics group versus controls on: 1) clinical core symptoms; 2) cognition;3)metabolic related markers.

Start: November 2017

Adapting and Examining Collaborative Decision Skills Training Among Veterans With Serious Mental Illness

Recovery-oriented care is an imperative for the VA, particularly in mental health programming for Veterans with serious mental illness (SMI). Collaborative decision-making (CDM) is a recovery-oriented approach to treatment decision-making that assigns equal participation and obligation to patients and providers across all aspects of decision-making, thereby empowering patients and facilitating better decision-making based on patient values and preferences. CDM is associated with several important outcomes including improved treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low, and there is not yet an evidence-based method to improve CDM. Improving Veteran skill sets associated with engaging in CDM is a potential intervention strategy. Collaborative Decision Skills Training (CDST) is a promising new intervention that was previously developed by the applicant for use in adult civilians with SMI and found to improve relevant skills and improve sense of personal recovery. The proposed study has two primary stages. First, a small, one-armed, open label trial will establish CDST's feasibility will evaluate CDST among 12 Veterans with SMI receiving services at the VA San Diego Psychosocial Rehabilitation and Recovery Center (PRRC) and identify and complete any needed adaptations to CDST. Stakeholder feedback from Veterans, VA clinicians, and VA administrators will be collected to assess Veteran needs and service context to identify any needed adaptations to the CDST manual or the delivery of CDST to maximize its impact and feasibility. The developers of CDST will review all feedback and make final decisions about adaptations to ensure that CDST retains its essential components to protect against loss of efficacy. For example, a recommendation to adjust role-play topics to better reflect the needs of Veterans would be accepted because it would increase CDST's relevance without impairing its integrity, but a recommendation to remove all role-plays would not be accepted because it would cause loss of a key component. Second, CDST will be compared to active control (AC) using a randomized clinical trial of 72 Veterans. The primary outcome measure will be functioning within the rehabilitation context, operationalized as frequency of Veteran CDM behaviors during Veteran-provider interactions. Secondary outcomes are treatment attendance, engagement, satisfaction, and motivation, along with treatment outcomes (i.e., rehabilitation goal attainment, sense of personal recovery, symptom severity, and social functioning). Three exploratory outcomes will be assessed: Veteran-initiated collaborative behaviors, acute service use and provider attitudes and behavior. Veterans will be randomly assigned to CDST or AC conditions. Veterans in the both groups will attend eight hour-long group sessions held over eight weeks. All Veterans will complete an assessment battery at baseline, post-intervention, and at three-month post-intervention follow-up. Following the trial and adaptation phase, the findings will be used to develop a CDST service delivery manual and design a logical subsequent study. The results of the proposed study will inform the potential for larger trials of CDST and the utility of providing CDST broadly to Veterans with SMI. The results of this study will expand current understanding of CDM among Veterans with SMI by providing data that will: 1) identify adaptations needed to optimize CDST for Veterans receiving services in PRRCs; 2) identify possible benefits of CDST; 3) inform development of alternate interventions or methods to improve CDM; and 4) further elucidate CDM and associated treatment processes among Veterans with SMI receiving VA rehabilitation services.

Start: December 2021

Mindfulness and Cognition in Schizophrenia

Mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. In schizophrenia, despite the positive effect of treatments on symptoms (delusions and hallucinations), patients have altered markers of the parasympathetic (high frequency, HF) system. The investigator propose a session of Mindfulness Based Stress Reduction (MBSR) for patients suffering from schizophrenia in order to measure the impact on the parasympathetic system (HF), self-awareness (being well in one's body and being aware of their own actions; EASE) and cognition (attention) in relation to the management of conflicts or emotions. The study compare with patients who receive a session of techniques based on the management of emotions and social cognition (cinemotion, Michael's Game and Tom Remed).

Start: September 2018

tDCS, Stress and Risk for Schizophrenia

An exacerbated response to stress mediated by activation of the Hypothalamo-Pituitary-Adrenocortical (HPA) axis is thought to play an important role in the onset, worsening and relapse of schizophrenia. Subjects at risk for schizophrenia (unaffected siblings of patients) displayed an intermediate hyperreactivity to stress as compared with patients and healthy controls. Symptoms of schizophrenia can be reduced with noninvasive brain stimulation (NIBS) applied over the dorsolateral prefrontal cortex (DLPFC). Importantly, this same DLPFC NIBS protocol can modulate decision making processes and modulate biological reactivity to stress by decreasing salivary cortisol concentration in acute stress condition.

Start: May 2019

Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology

Childhood trauma is known as a vulnerability factor in schizophrenia. In healthy volunteers, these adversities are linked to a decrease of grey matter of the brain, similar to those observed in schizophrenia. In a previous study based on Voxel-Based Morphometry (VBM), including 21 schizophrenic patients and 30 healthy volunteers, the investigators shown a negative correlation between emotional neglect (important dimension in childhood trauma) and grey matter decrease. This strong correlation was significantly higher in schizophrenic patients than in healthy volunteers, suggesting a higher genetic predisposition to environmental factors in schizophrenic people. Currently, interaction between genetic predisposition and environmental stress factors is the major model for understanding in schizophrenia. In order to analyze both effects on human body, particularly on brain, several studies currently focus on the product of genetic expression, the ribonucleic acid (ARN). The purpose of this study is to provide an explanatory model of links between childhood trauma, candidate gene for schizophrenia expression, cerebral morphology and schizophrenic symptomatology. Using conceptual framework of stress vulnerability, structural equation modeling (SEM) will allow testing causal link between these different variables.

Start: November 2018

Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia

This is an open-label study to determine the pharmacokinetics, safety and tolerability of single ascending doses of lumateperone long-acting injectable formulation in patients with schizophrenia. Patients will be enrolled in one of up to three cohorts. All patients will receive oral lumateperone for 5 days, followed by a 5-day washout of oral lumateperone, then followed by a single dose of lumateperone LAI.

Start: December 2020