ClinicalTrials.gg
RecruitingNCT06573320Updated Aug 27, 2024

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

An interventional study of physical exercise in Schizophrenia, Clozapine and Exercise, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Mar 2024, registered Aug 2024).
  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Schizophrenia
  • Clozapine
  • Exercise
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 60 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital is the lead sponsor of 78 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients treated who were diagnosed with schizophrenia according to 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

Exclusion Criteria:

  • pregnancy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    physical exercise group

    physical exercise

    Other: physical exercise

  • No intervention
    control group

    no intervention

Interventions

  • Otherphysical exercise

    physical exercise

06

What researchers measure

Primary outcomes

  1. Montreal Cognitive Assessment (MOCA)

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

    Time frame: 12 weeks

  2. 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)

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Kartal Dr Lütfi Kırdar Şehir Hastanesi
    İstanbul, Turkey
    Recruiting
    • Kartal Dr Lütfi Kırdar Şehir Hastanesi · Contact
    • İsmail Koç · Principal investigator
    • Ebru Akbuga Koc · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Aug 2024, 5 months after the start.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 5 months is below that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2024
First posted
Aug 27, 2024
StartActual
Mar 14, 2024
Primary completionEst.
Aug 26, 2024
CompletionEst.
Aug 31, 2024
Last update
Aug 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06573320
Lead sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible party
İsmail Koç (Assistant Professor, Dr. Lutfi Kirdar Kartal Training and Research Hospital) — Principal investigator
First posted
Aug 27, 2024
Start date
Mar 14, 2024
Primary completion
Aug 26, 2024 (estimated)
Completion
Aug 31, 2024 (estimated)
Last update
Aug 27, 2024

Study contacts

Ebru Akbuga Koc
Contact
ebruakbuga@gmail.com
0216

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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