Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): Substudy Site Copenhagen

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators want to relate disturbances in first-episode schizophrenic patients in (dopaminergic) D2 receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, the investigators want to examine the influence of D2 receptor blockade on these disturbances. The investigators expect disturbances in the dopaminergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and investigators expect D2 receptor blockade to reverse some of the functional and cognitive impairments. The investigators do not expect any effect of treatment on brain structure.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Birte Glenthoj
• Collaborators: Copenhagen Hospital Corporation; Glostrup University Hospital, Copenhagen; Institute of Psychiatry, London; Rigshospitalet, Denmark; UMC Utrecht
• Treatments: Amisulpride; Sulpiride; Sultopride

Criteria

Inclusion Criteria:

• Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV)

• Age 18-40 years

• Written informed consent.

Exclusion Criteria:

• A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years.

• Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime.

• Intolerance to one of the drugs in this study. Patients who are coercively treated at a psychiatric ward (based on a judicial ruling)

• Patients who are represented by a legal ward or under legal custody

• The presence of one or more of the contraindications against any of the study drugs as mentioned in the SPC texts

• Pregnancy, as determined through a pregnancy test, or lactation