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Clinical Trials/NCT06573320
NCT06573320
Recruiting
N/A

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 Hospital1 site in 1 country60 target enrollmentMarch 14, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Enrollment
60
Locations
1
Primary Endpoint
Montreal Cognitive Assessment (MOCA)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 14, 2024
End Date
August 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

İsmail Koç

Assistant Professor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • 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,

Exclusion Criteria

  • pregnancy

Outcomes

Primary Outcomes

Montreal Cognitive Assessment (MOCA)

Time Frame: 12 weeks

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

Positive and Negative Syndrome Scale (PANSS)

Time Frame: 12 weeks

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

Study Sites (1)

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