Last updated: November 17, 2023
Sponsor: LMU Klinikum
Overall Status: Active - Recruiting
Phase
N/A
Condition
Tourette's Syndrome
Mood Disorders
Schizotypal Personality Disorder (Spd)
Treatment
Aerobic Endurance Training
Flexibility, strengthening and balance training
Clinical Study ID
NCT05956327
BI 576/9-1, FA 241/21-1
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent for voluntary study participation.
- Patients with schizophrenia: diagnosis of schizophrenic psychosis according to ICD10and DSM V,
- Positive And Negative Syndrome Scale (PANSS) total score ≤ 75 before the start of theintervention
- Reliable contraception in women of childbearing age
- Patients must have been treated with individualized medication according to validtreatment guidelines. All antipsychotic substances are allowed, also as depotmedication. Treatment with one as well as with two antipsychotic substances ispossible. The additional administration of low- and medium-potency antipsychoticsubstances as on-demand medication for the treatment of agitation and sleep disordersis possible, provided that the daily dosage of 150 CPZ units is not exceeded. Theactive substance and dose of the individualized antipsychotic medication used toachieve the inclusion criterion of psychopathological symptom remission must beconstant for at least 2 weeks before inclusion in the study.
Exclusion
Exclusion Criteria:
- Lack of reliability and sanity (examined by an independent psychiatrist)
- Positive urine drug screen for illicit drugs (except benzodiazepines)
- Acute suicide risk
- Other relevant psychiatric axis-I disorders according to the diagnostic testingprocedure (Mini International Neuropsychiatric Interview, MINI)
- Other relevant neurological or other disorders
- Pregnancy or lactation
Study Design
Total Participants: 156
Treatment Group(s): 2
Primary Treatment: Aerobic Endurance Training
Phase:
Study Start date:
September 29, 2023
Estimated Completion Date:
September 30, 2026
Connect with a study center
LMU Klinikum
Munich, Bavaria 80336
GermanyActive - Recruiting
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