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English: Are medications used against symptoms in patients with schizophrenia, e.g. hallucinations and delusions, toxic or protective for the nervous system? A Long-term comparison of Two Treatment strategies.

Phase 1
Conditions
Schizophrenia
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Registration Number
EUCTR2016-001554-18-DE
Lead Sponsor
RWTH Aachen University represented by the Rector, represented by the Dean of the Medical Faculty
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
544
Inclusion Criteria

1.Patients with diagnosis schizophrenia according to DSM-V
2.Age 18-65 years
3.Written declaration of consent
4.Subjects being contractually and mentally capable to attend the medical staffs’ orders.
5.MRI capability
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1.Relevant somatic diseases, which could have an impact on the conduct of the study based on clinical judgement of the treating physician (e.g. epilepsy, cancer)
2.Prior insufficiently documented drug therapy with antipsychotics
3.Magnetic metals in and on the body, cardiac pacemakers and body piercings.
4.Pregnancy or lactation
5.Hospitalization of the patient ordered by the court or public authorities
6.Relationship of dependence or employment to sponsor or investigator
8.Simultaneous participation in another clinical trial (participation in an APIC subproject excluded)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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