Active clinical trials for "Schizophrenia"

A Phase 3, Multicenter, Two-part Study with a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects with DSM-5 Schizophrenia

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending intramuscular doses of MK-5720, and the safety and tolerability of multiple once-daily oral doses of MK-8189, in participants with schizophrenia. The primary study hypothesis is that the administration of MK-5720 is safe and well tolerated.

This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.

Recent studies indicated positive effects of mindfulness-based interventions (MBI) for schizophrenia (SCZ), but also on oxytocin (OXT) levels in healthy persons. It was also shown that response to MBI could be shaped by genetic factors. However, the interplay between mindfulness and empathy and genetic factors with the oxytocinergic system has not yet been examined in SCZ. The aim of the current explorative study is to (1) explore the effect of mindfulness-based group therapy (MBGT) on OXT levels as well as empathy in persons with SCZ; (2) investigate whether polygenic risk scores (PRS) for empathy can predict empathy levels in persons with SCZ; (3) investigate whether PRS for empathy and specific genetic configurations in the oxytocin receptors are associated with MBGT outcomes and OXT levels; 4) examine changes in positive- and negative symptoms, depression, anxiety, social functioning, and mindfulness at a within-group level and between both conditions. A parallel-group, proof-of-concept randomized controlled trial with 30 participants allocated to each trial arm (N = 60) will be conducted. Participants will be randomly assigned to MBGT alongside treatment as usual (MBGT+TAU) or treatment as usual (TAU). For a treatment period of four weeks, participants will receive weekly MBGT sessions. Four weeks after baseline assessments (T0), post-intervention assessments (T1) will take place. As a pilot study, effect sizes will be estimated for within- and between-group effects with corresponding confidence intervals. Outcomes of our proof-of-concept study can provide insight into potential biological mechanisms underlying mindfulness in SCZ, determine a valid biomarker associated with empathy and negative symptoms and pave the way for a personalized treatment approach for individuals with SCZ.

Many individuals with serious mental illness have difficulty accurately interpreting interpersonal cues and effectively engaging in social exchanges. Difficulties related to the interpersonal aspects of work can lead to isolation, poor productivity, and job loss. The goals of this study are to: 1) adapt an evidence-based social cognitive skills intervention for work settings and use with Veterans, 2) examine the acceptability of the work focused skills training intervention, 3) assess the feasibility of combining the social cognitive skills training program with supported employment, and 4) examine change on functional outcomes. The current study will use feedback from veteran and employment specialist stakeholders to adapt an evidence-based social cognitive skills training program, Social Cognition and Interaction Training (SCIT). The intervention will be modified to tailor it to work relationships and to address any unique relationship concerns among Veterans that are identified by stakeholders. SCIT-Work Edition (SCIT-WE) will add: 1) education about work-related social norms; 2) examples of work-related social interactions that require perspective taking and problem- solving; 3) individual sessions with the study therapist to enhance learning and relevance to each participant's goals; 4) structured interactions with the participant's employment specialist to practice skills outside of group; and 5) skill application sessions with the participant's employment specialist that prompt use of skills after training is completed. SCIT-WE will be developed and piloted in an open trial with 20 Veterans enrolled in the supported employment program at the Minneapolis VA who have a qualifying serious mental illness diagnosis. SCIT-WE will be offered for 2 hours weekly over 13 weeks, when most participants are in the job development and job search phases of supported employment. While participating in the group skills training, participants will have weekly, individual homework review sessions with the group facilitator to promote understanding of the skills and to discuss relevance of the skills to personal goals. Participants also will practice skills weekly with their employment specialist for 10-15 minutes to promote use of skills outside of group sessions. In the 3-months following skills training completion, participants will complete 10 15-minute skills review sessions with their employment specialist to encourage continued skill application in a work setting. Participants will complete assessments at baseline, before receiving the intervention; 3-months post-enrollment, after participating in a weekly skills training group; and 6-months post-enrollment, after receiving 10 additional individual skills review sessions with their employment specialist. Accessibility will be measured with rate of treatment uptake, rate of treatment completion, and participant attitudes toward the intervention. Feasibility of the intervention will be assessed by examining retention in supported employment and the study at 3- and 6-months post-enrollment. Impact of the intervention will be examined with measures of quality of life, social adjustment, self-efficacy, and work relationship quality. It is hypothesized that the intervention will be acceptable to Veterans. The investigators predict a 50% treatment uptake rate, a 70% intervention completion rate, and positive ratings on measures of satisfaction, interest, and value. The investigators hypothesize that it will be feasible to complete this intervention in combination with supported employment activities. The investigators predict that retention in both skills training and supported employment will be 75% at 3-months post-enrollment and 60% 6-months post enrollment. The investigators hypothesize that positive change will be seen at 3-months post-enrollment and sustained at 6-months post-enrollment on measures of quality of life and social adjustment. The investigators predicted that self-efficacy regarding return to work will be improved at 3-months post-enrollment. The investigators predict that Veterans will report being productive and having positive work relationships 6-months post-enrollment. The findings will inform the development of a novel intervention targeting the social and functional impairments associated with serious mental illness. The knowledge gained from this study will guide the development of the next generation of interventions. Given that employment is a critical part of recovery, advancement in therapeutic interventions that support Veterans in this process will be of significance.

The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals with schizophrenia.

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of CVL-231 (Emraclidine) (15 mg QD and 30 mg QD) in male and female participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.

The purpose of this study is to investigate the safety, tolerability and pharmacokinetic characteristics of JX11502MA capsule on healthy human, and to explore the relationship between the dose, pharmacokinetic parameters and safety of JX11502MA capsule，so as to provide basis for the follow-up clinical trials (multi-dose tolerability, pharmacokinetics and phase II trial, etc.).