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临床试验/NCT06573320
NCT06573320招募中不适用

Investigating the Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine

Dr. Lutfi Kirdar Kartal Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Montreal Cognitive Assessment (MOCA)

研究概览

简要总结

This prospective study aims to investigate the effects of exercise on clinical symptoms, cognitive performance, and quality of life in schizophrenia patients treated with Clozapine.

详细描述

The first developed atypical antipsychotic is clozapine. Its efficacy has been demonstrated in individuals with schizophrenia who have insufficient response to other antipsychotic therapies; nonetheless, its adverse effect profile is extensive. Among the antipsychotic medications now available, clozapine is not utilized as a first-line therapy because of major side effects such agranulocytosis. Increased salivation, sleepiness, weight gain, changes in blood pressure (sometimes an increase, sometimes a drop), elevated heart rate, dizziness, exhaustion, constipation, fever, and nocturnal enuresis are common adverse effects of clozapine usage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients treated who were diagnosed with schizophrenia according to DSM-V criteria by psychiatrist at the Turkish Ministry of Health Kartal Dr. Lütfi Kırdar City Hospital
  • using a therapeutic dose of 300-500 mg/day of clozapine,

排除标准

  • pregnancy

结局指标

主要结局

Montreal Cognitive Assessment (MOCA)

时间窗: 12 weeks

OCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.

Positive and Negative Syndrome Scale (PANSS)

时间窗: 12 weeks

To evaluate clinical symptoms, both the exercise and control groups will be assessed by using the Positive and Negative Syndrome Scale (PANSS)

次要结局

未报告次要终点

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

İsmail Koç

Assistant Professor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (2)

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