Overview

Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

Status:
Completed
Trial end date:
2021-01-01
Target enrollment:
0
Participant gender:
All
Summary
The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive tests, EEG, and PET-scannings.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Copenhagen
Treatments:
Antipsychotic Agents
Aripiprazole
Criteria
Inclusion Criteria Patients:

- Fulfilling the diagnostic criteria of schizophrenia or schizoaffective disorder
according to ICD-10 (International Classification of Diseases version 10) or DSM-IV/V
(Diagnostic and Statistical Manual version 4 /5)

- Age 18-45 years

- Never treated with antipsychotic compounds or central nervous system (CNS) stimulants

- Legally competent

Inclusion criteria controls:

- Matching patients on age (+/- 2 years), sex and parental socioeconomic status

- Age 18-45 years

- No psychiatric or physical disease

Exclusion Criteria patients:

- Substance abuse on a daily basis during the last 3 month or patients fulfilling the
criteria of ongoing substance abuse due to ICD-10/DSM-IV/V

- Treatment with antidepressant during the last 30 days

- Head injury with more than 5 minutes of unconsciousness

- Patients involuntarily admitted or treated

- Components of metal implanted by operation

- Pacemaker

- Pregnancy

- Severe physical illness

Exclusion criteria controls

- First degree relatives with psychiatric disease

- Substance abuse during the last 3 month or positive screening of drugs in urine-sample

- Head injury with more than 5 minutes of unconsciousness

- Components of metal implanted by operation

- Pacemaker

- Pregnancy

- Severe physical illness