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NCT Number: NCT06573320

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

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.

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Key information

Conditions

Schizophrenia Behavior Clozapine Exercise Mental Disorders Motor Activity Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr Lütfi Kırdar Şehir Hastanesi

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ebru Akbuga Koc

PRINCIPAL_INVESTIGATOR

Kartal Dr Lütfi Kırdar Şehir Hastanesi

CONTACT

İsmail Koç

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Other

physical exercise

Primary outcomes

  1. Montreal Cognitive Assessment (MOCA)

    Time frame: 12 weeks

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

  2. 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 contacts

Contact information is provided by the study sponsor or research team.

Ebru Akbuga Koc

CONTACT

[email protected]

0216

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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