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Schizophrenia clinical trials

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NCT ID: NCT06286202 Not yet recruiting - Schizophrenia Clinical Trials

Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial

Start date: May 2024
Phase: N/A
Study type: Interventional

Adults with serious mental illnesses (such as schizophrenia and schizoaffective disorders) often experience a range of cognitive difficulties (such as memory, problem solving difficulties) that affect their ability to lead meaningful life roles. Cognitive remediation is an intervention to address cognitive difficulties in this group of mental health service users. Its implementation in less well-resourced community-based settings is less well-studied. Therefore, the aims of the study are: - To investigate the effects of cognitive remediation on various cognitive skills (such as attention, memory, problem-solving, facial expression recognition, taking others' perspectives etc), for participants with schizophrenia or schizoaffective disorders in community mental health settings. - To investigate if factors such as participants' motivation for engagement and social interaction can affect changes in cognitive skills and functional ability. Participants in the treatment group will attend computer-based cognitive exercises to improve their cognitive skills. They will also participate in group sessions facilitated by therapists to learn how to utilize strategies learned from the computer sessions in their daily lives. Participants in the control group will attend the usual rehabilitation activities in their respective community-based psychiatric rehabilitation centers. This research study will compare the differences in their cognitive performance, functional ability and recovery immediately after the intervention and 8 weeks later.

NCT ID: NCT06284096 Not yet recruiting - Schizophrenia Clinical Trials

The Personal Recovery Based Psychoeducation For Schizophrenia

Start date: June 2024
Phase: N/A
Study type: Interventional

This project aims to introduce a new psychoeducation program that helps individuals with schizophrenia to recover subjectively. The program's effectiveness will be evaluated through a randomized controlled research design. The goal is not only to emphasize clinical recovery but also to highlight the importance of individual recovery and promote its implementation. In this context, the following hypotheses have been formulated. Research Question: 1) Does recovery-based psychoeducation have an impact on the subjective recovery level in individuals diagnosed with schizophrenia in remission? Hypotheses: H0a: Recovery-based psychoeducation does not affect the subjective recovery level in individuals diagnosed with schizophrenia in remission. H0b: Recovery-based psychoeducation does not effect on psychological resilience in individuals diagnosed with schizophrenia in remission. H0c: Recovery-based psychoeducation does not effect on hope in individuals diagnosed with schizophrenia in remission. H1a: Recovery-based psychoeducation affects the subjective recovery level in individuals diagnosed with schizophrenia in remission. H1b: Recovery-based psychoeducation has an effect on psychological resilience in individuals diagnosed with schizophrenia in remission. H1c: Recovery-based psychoeducation has an effect on hope in individuals diagnosed with schizophrenia in remission.

NCT ID: NCT06278532 Recruiting - Schizophrenia Clinical Trials

Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS

Start date: December 11, 2023
Phase:
Study type: Observational

This study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale in a Lithuanian sample. This will be done by comparing results obtained from the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale with results obtained from the Positive and Negative Symptoms Scale, the Montgomery Asberg Depression Rating Scale, and the Montreal Cognitive Assessment test.

NCT ID: NCT06278246 Not yet recruiting - Schizophrenia Clinical Trials

Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography

Start date: February 2024
Phase:
Study type: Observational

Within the schizophrenia population, there are individuals that respond to first-line antipsychotic treatments while others do not. The availability of muscarinic M4 subtype receptors (M4R) may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not. The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls. In addition, M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures. This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options, particularly for cognitive deficits and negative symptoms.

NCT ID: NCT06276361 Recruiting - Schizophrenia Clinical Trials

Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia

QUARTZ
Start date: September 26, 2023
Phase: Phase 1
Study type: Interventional

This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia.

NCT ID: NCT06275451 Not yet recruiting - Schizophrenia Clinical Trials

Qualitative Study of Emotional Regulation in Schizophrenia

QUALI-RES
Start date: February 2024
Phase:
Study type: Observational

The main aim of this study is to investigate emotional regulation in individuals with schizophrenia using a qualitative methodology (semi-structured interview) and, therefore, from the person's point of view. Given the qualitative nature of the methodology used in this study, the investigators have no specific hypothesis. The investigators have a general hypothesis suggesting that the patients' discourse will enable us to highlight the emotional regulation difficulties described in the literature.

NCT ID: NCT06270108 Recruiting - Healthy Controls Clinical Trials

The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia

RESTORE
Start date: November 14, 2022
Phase: Early Phase 1
Study type: Interventional

The goal of this basic science study is to to explore the responsivity of glutamate in the brain of treatment-resistant schizophrenia patients to the drug riluzole. The main aims of the study are: To assess the role of glutamate in treatment-resistant schizophrenia using magnetic resonance spectroscopy. To assess the relationship between glutamate levels and brain structural and functional measures (using: structural MRI; functional MRI (fMRI) and arterial spin labelling (ASL)) at baseline. To assess the relationship between longitudinal change in glutamate levels and brain structural and functional measures. To assess the relationship between longitudinal change in glutamate levels and changes in psychopathology. The researchers will compare the changes with healthy controls and those without treatment-resistant schizophrenia.

NCT ID: NCT06257056 Recruiting - Clinical trials for Treatment-Refractory Schizophrenia

Deep Brain Stimulation for Psychosis

Start date: April 3, 2024
Phase: N/A
Study type: Interventional

There are three hypotheses proposed for this study: 1) Participants will report no unanticipated serious adverse events during the eight months of treatment. 2) Investigators will successfully model psychotic versus non-psychotic brain states using support vector machine (SVM) classifiers. 3) Participants specific brain stimulation parameters can induce a change in the brain state consistent with non-psychotic states as measured by classifier output. Hypotheses 1, 2, and 3 address safety and tolerability, efficacy, and the putative mechanism of successful treatment. The overall objective is to use next generation Deep Brain Stimulation (DBS) combined with antecedent stereo electroencephalogram (SEEG) mapping to establish a new therapy for treatment-refractory schizophrenia given the limitations of current treatment modalities. The primary objective is to demonstrate safety of acute and chronic network guided stimulation for treatment-refractory schizophrenia. Exploratory Objectives: 1. Use intracranial mapping (SEEG) combined with pharmacological manipulation of psychotic states to create a protocol for participant specific deep brain stimulation to treat treatment-refractory schizophrenia. 2. Develop closed loop stimulation protocols to modify brain states during psychotic brain activity induced by low-dose ketamine administration. 3. Investigate the use of mnemonic similarity to characterize brain networks related to symptoms of treatment-refractory schizophrenia. 4. Treatment-related objectives: Record a reduction in psychotic symptoms, as well as an improvement in psychosocial function and cognition.

NCT ID: NCT06253546 Recruiting - Schizophrenia Clinical Trials

Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia

Start date: March 28, 2024
Phase: Phase 1
Study type: Interventional

Primary Objective: To evaluate the safety and tolerability of single doses of TV-44749 for subcutaneous (sc) use in Chinese participants with schizophrenia. Secondary Objectives: - To evaluate the pharmacokinetics (PK) of single doses of TV-44749 administered sc. - To evaluate the pharmacokinetics of oral olanzapine tablets following multiple dose administration. - To monitor the safety and tolerability of multiple doses of oral olanzapine tablets given in the study.

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.