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Schizophrenia clinical trials

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NCT ID: NCT06440200 Enrolling by invitation - Schizophrenia Clinical Trials

Exploring the Health Effects of Group Game-based Activities on Individuals With Chronic Mental Illness

Start date: January 18, 2024
Phase: N/A
Study type: Interventional

This study aims to explore the health effects of group games for patients with chronic mental illness. The goal of this clinical intervention study is to compare the efficacy of group games in two ways (experimental group/ group game-based or control group) to improve the health of patients with chronic mental illness. The main questions it aims to answer are: The efficacy of applying group game-based activities to increase interest and improve the physical fitness of patients with chronic mental illness. Also, the goal of this clinical interventional study is to clarify the positive benefits of psychological and social aspects. Subjects will be asked to complete the questionnaire and physical ability examination after filling out the consent of this study. Participants will be randomly divided into two groups. Participants in the experimental group will accept the group game-based activities for 12 weeks (twice per week, 22 times). In contrast, Participants in the control group will accept the activities the psychiatric day wards and halfway house offer as usual. After 12 weeks of intervention, The Participants in both groups will be asked to fill out the questionnaire and physical ability examination. One month later, Participants in both groups will be asked to fill out the questionnaire and physical ability examination again. The study will last for 4 months. The time points for completing the questionnaire are listed following: Baseline/ pre-intervention test(T1), First post-intervention test (T2, 12 weeks later) and Second post-intervention test (T3, 4 weeks later). The researchers will compare the difference in effectiveness between the two groups.

NCT ID: NCT06251908 Enrolling by invitation - Clinical trials for Schizophrenia Spectrum and Other Psychotic Disorders

REWRITALIZE Your Recovery - Evaluation of a Creative Writing Group Intervention

REWR
Start date: February 12, 2024
Phase: N/A
Study type: Interventional

Health institutes call for psychosocial interventions and recovery-oriented approaches as supplement to pharmacological treatment for mental health disorders. Participatory art interventions have been suggested to be promising in promoting recovery by stimulating connectedness, hope, renegotiation of identity, participatory meaning-making and empowerment. In spite of promising findings, the evidence base is still thin. We have developed Rewritalize (REWR), a manualised, recovery-oriented fifteen-session participatory creative writing group intervention, led by a professional author and attended by a mental health professional. Participants are introduced to literary forms, write spontaneously on those forms, share their texts and engage in reflective discussions about them. It is designed to provide a holding and non-stigmatising environment, structure and continuity, and to promote self-expression, playful experimentation, agency, recognition, participatory meaning-making, renegotiation of identity and social engagement. The aim of the present project is to evaluate REWR for persons with schizophrenia spectrum disorders. This study is a randomised controlled clinical trial focusing on clinical and personal recovery. This study is an investigator-initiated, randomised, two-arm, single-blinded, multi-center, waiting list trial. Participants (n=266) with schizophrenia spectrum disorders (age: 18-35) will be recruited at six psychiatric centres in region Zealand and randomised to active (creative writing group + treatment as usual) or control (waiting list + treatment as usual) condition. Assessments will be collected pre- and post-intervention and six months after end of intervention. The primary outcome measure will be the questionnaire of the process of recovery administered at the end of the intervention. Secondary outcome measures comprise measures of recovery, self-efficacy and mentalising assessed at the end of the intervention and six months after the the intervention ends. The post-intervention measures will be compared between active and control groups by means of independent sample t-tests.

NCT ID: NCT05741528 Enrolling by invitation - Schizophrenia Clinical Trials

An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication

Start date: March 31, 2023
Phase: Phase 3
Study type: Interventional

An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.

NCT ID: NCT05703412 Enrolling by invitation - Schizophrenia Clinical Trials

Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness

tFOCUS
Start date: February 14, 2023
Phase: N/A
Study type: Interventional

The overall aim of this program of research is to improve the continuity of care for patients with serious mental illness (SMI) by supporting a safer and more efficient bridge from hospital to outpatient care using a mobile device-delivered app called Transition-FOCUS (tFOCUS), which has previously been tested in community samples. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, multi-component mHealth intervention.

NCT ID: NCT05695144 Enrolling by invitation - Clinical trials for Schizophrenia Negative Type

tDCS Combined With rTMS for Negative Symptoms of Schizophrenia

NIBSNeS
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Despite major advances in the field of psychopharmacology in recent years, the majority of treated schizophrenia patients retain disabling symptoms, most commonly a variety of negative symptoms. Currently, clinical treatment of schizophrenia remains dominated by pharmacological control. The current use of antipsychotic medications is effective in controlling the positive symptoms of schizophrenia, but has little effect on the negative symptoms. Neuroimaging and neurophysiological studies have shown that negative symptoms are associated with abnormal brain activity in the combined right and left dorsolateral prefrontal and temporoparietal joint regions, and that physical therapy techniques can modulate cortical activity. Therefore, this study aims to investigate the efficacy of transcranial direct current stimulation(tDCS) combined with repetitive transcranial magnetic stimulation(rTMS) on negative symptoms in patients with schizophrenia and to explore possible mechanisms. The double-blind randomized placebo-controlled study comparing active tDCS stimulation combined with active rTMS stimulation, active rTMS stimulation combined with sham tDCS stimulation, and active tDCS stimulation combined with sham rTMS stimulation to sham tDCS stimulation combined with sham rTMS stimulation at 4 weeks of treatment and 2 weeks of follow-up in patients with predominantly negative symptoms with schizophrenia was studied for efficacy. In addition to the primary observation of changes in the Negative Symptom Assessment Scale (SANS), secondary outcomes include changes in Positive and Negative symptom scale (PANSS) total and negative total scores, changes in the MATRICS Consensus Cognitive Battery (MCCB), changes in local brain activity (functional magnetic resonance imaging, fMRI), white matter integrity (diffusion tensor imaging, DTI), changes in laboratory examination indices changes and changes in psycho-behavioral and EEG index. This is the first clinical trial combining tDCS with rTMS for the treatment of schizophrenia patients with predominantly negative symptoms. This study will provide solid evidence for the combination of tDCS with rTMS for the treatment of negative symptoms in schizophrenia. This study will also help to further explore the mechanisms of tDCS combined with rTMS for the treatment of negative symptoms in schizophrenia in terms of imaging and behavior.

NCT ID: NCT05567848 Enrolling by invitation - Schizophrenia Clinical Trials

Accelerated TMS in Psychosis

ATP
Start date: November 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study is to determine the tolerability and efficacy of an accelerated schedule of Transcranial Magnetic Stimulation for treating symptoms of psychotic disorders such as schizophrenia.

NCT ID: NCT05532683 Enrolling by invitation - Psychosis Clinical Trials

Feasibility Trial of a Lifestyle Intervention for CHR-P

Start date: April 4, 2023
Phase: N/A
Study type: Interventional

The present study will assess the feasibility and social validity of an adjunctive health promotion group for youth and clinical high risk for psychosis (CHR-P). Youth participating in treatment at the Center for the Assessment and Prevention of Prodromal Sates (CAPPS) will be invited to participate in a weekly, adjunctive, closed psychoeducation group focused on sharing health promotion strategies and increasing health behaviors (e.g. improved sleep habits, increased participation in physical activity). The aim of the group will be to provide psychoeducation on lifestyle risk and protective factors for youth at risk for psychosis (i.e. experiencing subthreshold psychosis symptoms). Topics covered will include psychoeducation, goal setting, stress management, sleep, physical activity, substance use, and nutrition. Evidence-based strategies to decrease risk factors and promote protective lifestyle factors for mental illness will be reviewed. Group leaders will utilize a motivational interviewing approach to facilitate the group. The group will complete nine weekly group sessions. The goal of our research is to 1) determine the feasibility of a novel group-based health promotion intervention, 2) assess the social validity of the group, 3) measure the effects of the intervention on stress, sleep, physical activity, substance use, and nutrition, and 4) measure preliminary effects on symptoms and functioning.

NCT ID: NCT05304767 Enrolling by invitation - Schizophrenia Clinical Trials

An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Start date: March 7, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily [BID]) in subjects with schizophrenia.

NCT ID: NCT05168007 Enrolling by invitation - Schizophrenia Clinical Trials

Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

Start date: November 19, 2021
Phase: Phase 3
Study type: Interventional

This Study is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/day and 6 mg/day in Patients with Acute Psychotic Episode of Schizophrenia.

NCT ID: NCT05127837 Enrolling by invitation - Schizophrenia Clinical Trials

CBTpro: Scaling up CBT for Psychosis Using Simulated Patients and Spoken Language Technologies

CBTpro
Start date: June 28, 2022
Phase: N/A
Study type: Interventional

The primary objective of this grant is to develop and evaluate an Artificial Intelligence-based clinical training tool--CBTpro--to support high-quality skills training in CBT for psychosis (CBTp). CBTpro will provide a rapid means of scaling and sustaining high-quality CBTp in routine care settings across the US.