Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05956327

Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training

Led by LMU Klinikum · Updated on 2023-11-21

156

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

L

LMU Klinikum

Lead Sponsor

G

German Research Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Aerobic endurance training has shown positive effects on symptoms, cognition, daily functioning, and the structure of the hippocampus in patients with schizophrenia. The study investigates genetic and epigenetic influences on neuroplastic changes following three months of endurance training. A control group performs flexibility, strength, and balance training. The main objective is to examine the association between a genetic risk score for schizophrenia and volume increase in the CA4/DG region of the hippocampus. Additional goals include examining changes in synapses, brain structure, function, and metabolism, as well as clinical symptoms and cognitive performance.

CONDITIONS

Official Title

Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent for voluntary study participation.
  • Diagnosis of schizophrenic psychosis according to ICD10 and DSM V.
  • Positive And Negative Syndrome Scale (PANSS) total score  75 before the start of the intervention.
  • Reliable contraception in women of childbearing age.
  • Treatment with individualized antipsychotic medication according to valid guidelines, with stable dose for at least 2 weeks before inclusion.
  • Allowed treatment with one or two antipsychotic substances, including depot medication.
  • Additional use of low- and medium-potency antipsychotics on demand allowed if daily dosage does not exceed 150 CPZ units.
Not Eligible

You will not qualify if you...

  • Lack of reliability and sanity as 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 Mini International Neuropsychiatric Interview (MINI).
  • Other relevant neurological or other disorders.
  • Pregnancy or lactation.

AI-Screening

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Trial Site Locations

Total: 1 location

1

LMU Klinikum

Munich, Bavaria, Germany, 80336

Actively Recruiting

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Research Team

I

Isabel Maurus, Dr.

CONTACT

L

Lukas Roell, M.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training | DecenTrialz