Clinical Research Directory

Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone

This study aims to evaluate the effectiveness of Ashwagandha (Withania somnifera) extract as an adjuvant therapy in patients with schizophrenia who are receiving risperidone. Schizophrenia is a chronic mental disorder associated with neuroinflammation and immune dysregulation, including increased levels of pro-inflammatory cytokines such as interleukin-1 beta (IL-1β). In this study, patients diagnosed with schizophrenia are given standard treatment with risperidone, with or without additional Ashwagandha extract. The primary outcomes are changes in Interleukin-1β levels and clinical symptoms assessed using the Positive and Negative Syndrome Scale (PANSS). The study aims to determine whether Ashwagandha extract supplementation can reduce inflammation and improve clinical symptoms in patients with schizophrenia. The findings support the use of Ashwagandha extract as a complementary therapy to enhance treatment outcomes in schizophrenia.

Effect of Cognitive Behavioral Therapy on Auditory Hallucinations and NLR in Schizophrenia Patients

This study aims to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) as an adjunctive treatment to pharmacotherapy in reducing auditory hallucinations and inflammation, as measured by the neutrophil-to-lymphocyte ratio (NLR), in patients with schizophrenia. Schizophrenia is a chronic psychiatric disorder characterized by positive symptoms, including auditory hallucinations, which significantly impair functioning and quality of life. While antipsychotic medications such as risperidone are effective in managing symptoms, a substantial proportion of patients continue to experience persistent hallucinations. Cognitive Behavioral Therapy (CBT) has been shown to improve coping strategies and reduce distress associated with hallucinations. Recent evidence suggests that inflammation plays a role in the pathophysiology of schizophrenia. The neutrophil-to-lymphocyte ratio (NLR) is a simple and accessible biomarker of systemic inflammation and has been associated with symptom severity in schizophrenia. However, limited studies have explored whether psychological interventions such as CBT can influence inflammatory markers. This study uses a quasi-experimental design involving two groups: an intervention group receiving CBT in addition to standard pharmacotherapy, and a control group receiving pharmacotherapy alone. CBT will be delivered in structured sessions focusing on cognitive restructuring, behavioral modification, and coping strategies for auditory hallucinations. Clinical outcomes will be assessed using the Psychotic Symptom Rating Scales (PSYRATS) for auditory hallucinations, while inflammatory status will be measured using NLR obtained from peripheral blood samples. Assessments will be conducted before and after the intervention period. The findings of this study are expected to provide evidence on the effectiveness of CBT not only in improving clinical symptoms but also in potentially modulating inflammatory processes in patients with schizophrenia.

Combined Exercise and PMS: Impact on Biopsychosocial Function in Older Adults With Schizophrenia

This project consists of two randomized parallel - group experiments targeting older adults with schizophrenia, aiming to evaluate the therapeutic effect of Peripheral Magnetic Stimulation (PMS). Experiment 1 (Efficacy of PMS): During a 4 - week intervention period, participants are randomly assigned to receive active PMS or sham PMS. The primary objective is to determine whether PMS can reduce the clinical symptom burden and improve biopsychosocial functioning compared with sham stimulation through electroencephalogram (EEG) signal acquisition and evaluation. Secondary objectives include the effects on cognition, mood, sleep, and health - related quality of life, as well as safety and tolerability (adverse events monitoring). Experiment 2 (Comparison of Intervention Effects): The subjects are randomly divided into three groups: exercise combined with PMS group, PMS alone group, and exercise alone group. Each group is arranged by relevant professionals to carry out the corresponding intervention for 4 weeks. The main purpose is to examine the differences in the effects of the three intervention methods (exercise combined with PMS, PMS alone, and exercise alone) in improving patients' conditions, including the impact on exercise - related physical performance, functional mobility, etc. Secondary objectives include the impact on overall function and quality of life, along with safety monitoring. In both experiments, outcome indicators are measured from baseline to post - intervention (and, where feasible, short - term follow - up) by assessors who are blinded to group allocation using appropriate tools. It is hypothesized that in Experiment 1, PMS will be superior to sham stimulation; in Experiment 2, the effect of exercise combined with PMS in improving patients' motor and related functions will be better than that of PMS alone or exercise alone, which supports PMS as a scalable auxiliary means for the rehabilitation of this population.

Video Game-facilitated Group Activity for Quality of Life and Social Function in Chronic Schizophrenia Inpatients.

The goal of this clinical trial is to learn if video game-facilitated group activity helps to improve the quality of life and social function in inpatients with chronic schizophrenia. The main questions it aims to answer are: * Does video game-facilitated group activity enhance the quality of life as measured by a standardized scale (WHOQOL) in patients with schizophrenia hospitalized in a psychiatric hospital? * Can video game-facilitated group activity promote social function as measured by a specific scale (PSP) in patients with schizophrenia hospitalized in a psychiatric hospital? Researchers will compare video game-facilitated group activity to regular occupational therapy to see if the intervention is beneficial to patients with chronic schizophrenia. Participants will: * Attend to video game-facilitated group activity or regular occupational therapy three times a week for 12 weeks. * Receive assessments upon and after the 12-week intervention, and another 12 weeks after the intervention ends.

Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia

The planned randomized, sham-controlled, double-blind, monocentric study aims to evaluate the effectiveness of intermittent Theta-Burst Stimulation (iTBS) on negative symptoms and cognitive deficits in schizophrenia. Both the cerebellar vermis and the left dorsolateral prefrontal cortex will be stimulated successively within the same session. The goal of this trial is to learn if intermittent theta-burst stimulation (iTBS) of the cerebellum and the left dorsolateral prefrontal cortext (DLPFC) can treat negative symptoms and improve cognition in patients with schizophrenia. The main question it aims to answer is: Does iTBS of the cerebellum and the left DLPFC improve negative symptoms in patients with schizophrenia? Researchers will compare iTBS to sham stimulation to see if iTBS improves negative symptoms. Participants will: * Receive 10 sessions of iTBS over the course of 2 weeks * Undergo extensive examination before iTBS treatment, immediately after iTBS treatment and 4 weeks after iTBS treatment. The examination includes assessment of negative symptoms; psychometric assessment of cognition, social cognition, depressive symptoms; functional magnetic resonance imaging; assessment of eye movements; blood and saliva sampling; assessment of adverse events and stimulation associated sensations. The study thus seeks to determine whether iTBS of the fronto-cerebellar network might improve negative symptoms and cognition by altering the network's functional activity. Additionally, it will investigate whether a pro-inflammatory cytokine profile could affect iTBS outcomes and whether inflammatory markers could be affected by iTBS.

ACT-Based Psychoeducation for Schizophrenia Caregivers

Schizophrenia is an important mental health problem that requires caregivers because it causes disability. With the efforts to move from a hospital-based model to a community-based model in mental health services, the care of schizophrenia patients is mainly provided by their families at home, creating a significant care burden on caregivers or, on the contrary, post-traumatic development is reported. Psychiatric nurses are responsible for evaluating the patient together with their family by taking these conditions into consideration when providing care to individuals with mental illness. As a principle of humanistic and holistic care, nursing interventions to be implemented by psychiatric nurses to develop caregivers' coping methods, reduce their care burden and contribute to their post-traumatic development are extremely important in terms of the effectiveness and efficiency of care. Acceptance and Commitment (ACT)-based psychoeducation, whose effectiveness has been reported in the literature, is an important application in providing care to patients and families in psychiatric nursing practices. ACT is among the third generation therapies that aim to keep individuals in the moment with awareness, adopt the willingness to accept events instead of struggling with them, and create an important source of power in taking actions in line with life values. In this study, 17 out of 34 individuals determined by statistical methods among the caregivers of schizophrenia patients will be included in the control group and monitored, while 17 will receive 8 sessions of ACT-based psychoeducation in the intervention group, and the effects of the education on caregiver burden, post-traumatic development, and psychological resilience will be evaluated. There are very few studies in the literature where ACT-based psychoeducation is applied to caregivers of schizophrenia patients. Although studies examining the effects on individuals' caregiver burden and psychological resilience are limited, no study has been found examining its effects on post-traumatic development, and this constitutes the original value of the study. As a result of this study, it is expected that ACT-based education will reduce the caregiver burden in schizophrenia caregivers and increase their psychological resilience through post-traumatic development.

The Effect of Psychosocial Skills Focused Group Psychoeducation in Schizophrenia Patients

The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. This research will be conducted in Giresun Community Mental Health Center. The study was planned as a randomized controlled pretest-posttest design. In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data. The sample size was calculated as 34 people (experimental group= 17, control group= 17). Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation.

Effects of Lurasidone on Left Ventricle Systolic Functions

The goal of our study to learn if lurasidone molecule which is used on patients with schizophrenia or bipolar disorder has any cardiotoxic effect.