Klecany

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

The present research project aims to contribute to the further development of accessible, evidence-based and safe care for people with sexual interest in children, and that are using child sexual abuse material (CSAM), so that these people can access treatment according to their needs and level of risk, with the objective of reducing the risk for child sexual abuse and improving the health of the group. The intervention will be available in seven languages and will be tested in six countries. Primary research questions: Does Mi Bridge increase the likelihood that individuals at high risk for committing child sexual abuse accept seeking treatment for problems related to sexual interest involving minors at a health care facility? Does Mi Bridge increase participants motivation for change regarding sexual behaviors involving minors? Secondary research questions: Does Mi Bridge increase the intention to seek treatment in the coming month for problems related to sexual interest involving minors at a health care facility? Does Mi Bridge decrease participants sexual interest involving children? Does Mi Bridge significantly decreases participants past week sexual behaviors involving children? Does Mi Bridge significantly decreases participants symptoms of depression? Is Mi Bridge effective in reducing certain dynamic risk factors for committing child sexual abuse? About the intervention. Mi Bridge is a series of up to five conversations between a practitioner and a study participant over three weeks to help the participants understand more about themselves and their willingness to change, and to help the participants connect with the care they need and want. The conversations are carried out as anonymous voice calls or anonymous text-based chat. Mi Bridge is based on the established and well-researched method of Motivational Interviewing, which has been shown to be effective in helping people achieve the desired changes for several lifestyle related problems. Research subjects will be recruited through Darknet and Clearnet. Darknet refers to websites that are accessible via Tor or similar services. The intervention is provided by practitioners and researchers in the relevant countries. Mi Bridge will be evaluated through an international multicenter study using randomized wait-list controlled design. The research subjects will sign a written consent form on the Iterapi platform without disclosing personal data such as name or location. During the subsequent screening interview via chat or voice call on Iterapi, participation criteria are ensured, questions are answered, and the consent to participate is confirmed. The research subjects are thus admitted to the study. After inclusion, participants answer the baseline survey which consists of validated self-assessment questionnaires with both multiple choice and free-text answers. Weekly during, after the waitlist, and after the therapeutic intervention, research subjects answer questions to evaluate the effectiveness and safety of the interventions. A Statistical Analysis Plan (SAP) based on pilot study is pre-registered at the OSF platform. The SAP describes sample size calculations, and planned analyses of outcome measures.

The present research project aims to contribute to the further development of accessible, evidence-based and safe care for people with concerns about their sexual interest regarding children, and that are using child sexual abuse material (CSAM), so that these people can access treatment according to their needs and level of risk, with the objective of reducing the risk for child sexual abuse and improving the health of the group. More concretely, we aim to evaluate a revised version of an already available cognitive-behavioral self-help program, ReDirection, with the aim of testing whether this intervention can reduce sexual interest regarding children and CSAM use, in a group of people assessed as being at low or medium risk of committing sexual abuse of children. The intervention will be available in seven languages and will be tested in six countries. Primary research question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors? Secondary research questions: Is ReDirection effective in reducing research subjects' overall risk of committing sexual acts involving children? Does ReDirection reduce specific dynamic risk factors for committing CSA? ReDirection is based on cognitive behavioral therapy and consists of five modules. The program aims to help participants reduce their CSAM use by gaining a better understanding of, and skills to manage risky sexual thoughts, feelings, and behaviors. At the end of the program, participants are offered an anonymous follow-up chat and if needed during the program, participants can contact a practitioner via chat. Research subjects will be recruited through Darknet and Clearnet. Darknet refers to websites that are accessible via TOR or similar services. The interventions are provided by practitioners and researchers in the relevant countries. ReDirection will be evaluated through an international multicenter study using randomized wait-list controlled design. The research subjects will sign a written consent form on the Iterapi platform without disclosing personal data such as name or location. During the subsequent screening interview via chat or voice call on Iterapi, participation criteria are ensured, questions are answered, and the consent to participate is confirmed. The research subjects are thus admitted to the study. After inclusion, participants answer the baseline survey which consists of validated self-assessment questionnaires with both multiple choice and free-text answers. Weekly during, after the waitlist, and after the therapeutic intervention, research subjects answer questions to evaluate the effectiveness and safety of the interventions. A Statistical Analysis Plan (SAP) based on pilot study is pre-registered at the OSF platform. The SAP describes sample size calculations, and planned analyses of outcome measures.

Researchers are conducting a multinational observational study to evaluate the feasibility of collecting speech and self-report data across six languages for AI-based relapse risk estimation in people with psychotic disorders. This study includes individuals at risk of relapse and healthy controls, aiming to explore new speech markers for predicting relapse while minimizing participant burden. It involves an international, multicenter design across diverse healthcare settings to ensure broad applicability. Participants will use a smartphone app to provide weekly speech recordings and self-report data over 12 months. These recordings are securely transferred and analyzed by an AI backend to calculate relapse risk scores, which are stored but not shared with treating clinicians. The study includes a Human-in-the-Loop quality control process with two independent reviewers assessing data accuracy and providing relapse risk estimates without influencing clinical care. Participants will attend three study visits at baseline, 6 months, and 12 months for additional assessments. During the study, researchers will evaluate user adherence, transcription quality, recording usability, overall system usability, and the performance of the monitoring system for relapse prediction. Assessments include clinical evaluations, functional and quality-of-life measures, and usability questionnaires. The total participation duration is 12 months, with ongoing monitoring and data collection to validate the AI system and discover novel speech markers associated with relapse risk.

Researchers are evaluating the effectiveness of virtual reality exposure therapy (VRET) as a treatment for obsessive-compulsive disorder (OCD) in a randomized controlled trial involving inpatients. Participants are assigned to one of three groups: a standard cognitive-behavioral therapy (CBT) program combined with VRET, a standard CBT program combined with virtual reality cognitive training aimed at improving cognitive flexibility, or a standard CBT program without any VR intervention. The study aims to compare treatment effects using various assessments and adherence monitoring.

Researchers are evaluating the effectiveness of virtual reality exposure therapy (VRET) as a treatment for obsessive-compulsive disorder (OCD) in outpatient psychiatry or clinical psychology settings. This study uses a within-subject design where participants first complete informed consent and baseline questionnaires, then spend five weeks on a waiting list before starting VRET. The study aims to assess the therapy's impact by comparing symptoms before and after treatment and monitoring adherence to exposure and response prevention tasks. Participants receive five weekly sessions of exposure therapy through a virtual reality headset, each lasting 30 to 40 minutes. The therapy takes place in a virtual environment called the "OCD house," visualized using immersive Meta Quest 2 VR glasses. The virtual scenarios include common household objects and situations that may trigger OCD symptoms, tailored to different OCD subtypes such as contamination, fear-of-harm, checking, symmetry, ordering, and hoarding. The therapist adjusts the difficulty level across four standardized stages and can interact with and guide the participant remotely using a streaming app on a tablet or phone. Throughout the study, participants complete repeated assessments including the Yale-Brown Obsessive-Compulsive Scale, Beck Depression Inventory, Beck Anxiety Inventory, Hierarchy of Fears, and the Spielberger State-Trait Anxiety Inventory-X2. These evaluations occur before the waiting period, after the waiting period (before therapy), after the final therapy session, and three months later at follow-up. The study monitors symptom changes, therapy adherence, and safety over the entire timeline to understand the effects of VRET on OCD symptoms.