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

Are Antipsychotics Neurotoxic or Neuroprotective? A Long-term Comparison of Two Treatment Strategies of Schizophrenia - Antipsychotic Induced Brain Changes (APIC)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00008018

Enrollment

544

Registered

2015-04-24

Start date

2015-06-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DSM-IV 295: Schizophrenia F20

Interventions

Group 1: Maintenance treatment (control): Treatment with antipsychotic drug (type not specified) for at least 12 months Group 2: Intermittent treatment (experimental): Treatment with antipsychotic dru

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactSabrina Schaffrath

Uniklinik RWTH Aachen

saschaffrath@ukaachen.de0241 8037191

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026