Antipsychotic Induced Structural and Functional Brain Changes

• Status: Terminated
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Continuation of antipsychotic drug treatment for at least 12 months after remission of the first psychotic episode represents the gold clinical standard, and it is recommended by all international treatment guidelines. Numerous studies have shown that the risk of relapse is significantly increased, if drug treatment is terminated prematurely. However, only a minority of patients achieve functional remission, even if they fully comply with treatment. Long-term adverse effects of the currently available drugs, specifically brain grey matter loss and development of supersensitivity psychosis, might outweigh their benefits. Thus, the current standard of long-term maintenance antipsychotic treatment, which has the primary goal of relapse prevention, has to be questioned. Here the investigators hypothesize that intermittent treatment (experimental) with antipsychotics, which is directed exclusively against the positive symptoms of Schizophrenia, is associated with less loss in total grey matter volume than maintenance treatment (control). Furthermore, the investigators hypothesise that this targeted treatment approach is associated with better functional outcome (fewer negative symptoms, better cognitive performance, better quality of life) than continuous antipsychotic treatment,although the latter is initially associated with fewer relapses.The aim of the present study is to compare two different drug therapies -maintenance therapy versus on-demand, intermittent therapy- in terms of their treatment's success and the structural changes in the brain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Treatments: Antipsychotic Agents

Criteria

Inclusion Criteria:

• Patients with diagnosis of schizophrenia according to DSM-5

• Age 18-65 years

• Written declaration of consent

• 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)