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

NCT ID: NCT06573320

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Clozapine Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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physical exercise group

physical exercise

Group Type EXPERIMENTAL

physical exercise

Intervention Type OTHER

physical exercise

control group

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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physical exercise

physical exercise

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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İsmail Koç

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kartal Dr Lütfi Kırdar Şehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ebru Akbuga Koc

Role: CONTACT

Facility Contacts

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Kartal Dr Lütfi Kırdar Şehir Hastanesi

Role: primary

Other Identifiers

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Keah

Identifier Type: -

Identifier Source: org_study_id

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