Are Antipsychotics Neurotoxic or Neuroprotective? A Long-term Comparison of Two Treatment Strategies of Schizophrenia

Phase 4

• Conditions: DSM-IV 295: Schizophrenia; F20; Schizophrenia

• Registration Number: DRKS00008018
• Lead Sponsor: RWTH Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-24
• Study Completion: 2020-09-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Patients with diagnosis of schizophrenia according to DSM-5
• Age 18-65 years
• Written informed consent prior to study participation
• Subjects being contractually and mentally capable to attend the medical staffs’ orders
• MRI capability

Exclusion Criteria

• 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)
• Prior insufficiently documented drug therapy with antipsychotics
• Magnetic metals in and on the body, cardiac pacemakers and body piercings
• Pregnancy or lactation
• Hospitalization of the patient ordered by the court or public authorities
• Relationship of dependence or employment to sponsor or investigator
• Simultaneous participation in another clinical trial (participation in an APIC subproject excluded)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total grey matter volume [Time Frame: after 12 months] comparing intermittent therapy with maintenance treatment via MRI examination at different measuring time points

Secondary Outcome Measures

Name	Time	Method
• Grey matter volume (hippocampus, prefrontal cortex) [Time Frame: after 6 and 24 months]:<br>change of volume<br><br>• Assessment of safety [Time Frame: after 6 and 12 months]:<br>Drop-out rates, extrapyramidal side effects (ESRS (Extrapyramidal Symptoms Rating Scale), BARS (Barnes Akathisia Rating Scale)); sexual function (Arizona Scale);<br>metabolic side effects (BMI, HbA1c, Glucose, Cholesterol, Triglycerides)<br><br>• Cognition and psychopathology [Time Frame: after 6 and 12 months]:<br>BACS (Brief Assessment of Cognition in Schizophrenia) and PANSS (Positive and Negative Symptoms Scale), CGI (Clinical Global Impression-Skala)<br><br>• Quality of life change [Time Frame: after 6 and 12 months]:<br>SF-36 (Short Form-36 Health Survey), GAF (Global Assessment of Functioning Scale), visual analogue scales