SchizophreniaNCT06573320
Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine
A study testing physical exercise in people with Schizophrenia and Clozapine, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Clozapine, Exercise
- What is being tested?
- physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kartal Dr Lütfi Kırdar Şehir Hastanesi
Istanbul
Kartal Dr Lütfi Kırdar Şehir Hastanesi
İsmail Koç
About this study
Official title: Investigating the 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.
Read the 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.
- Conditions
- Schizophrenia, Clozapine, Exercise
- Being tested
- physical exercise
- Medical subject headings
- Schizophrenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseOther
physical exercise
| Study group | Role | What they receive |
|---|---|---|
| physical exercise group | Experimental | physical exercise Receives: Other: physical exercise |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MOCA)
OCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Measured: 12 weeks
Positive and Negative Syndrome Scale (PANSS)
To evaluate clinical symptoms, both the exercise and control groups will be assessed by using the Positive and Negative Syndrome Scale (PANSS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start14 Mar 2024
- Primary completion26 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İsmail Koç, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573320
- Sponsor's protocol ID
- Keah
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine
- ClinicalTrials.gov ID
- NCT06573320
- Acronym / sponsor ID
- Keah
- Conditions
- Schizophrenia, Clozapine, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 26 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical exercise group | Experimental | Other: physical exercisephysical exercise |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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,
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exercisephysical exercise | Other | physical exercise group |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Schizophrenia and Clozapine, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebru Akbuga Koc (0216, ebruakbuga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MOCA) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.