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

NCT01555814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2016-10-26

No results posted yet for this study

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.

Conditions

  • Schizophrenia
  • Schizophreniform Disorder
  • Schizoaffective Disorder

Interventions

DRUG

Amisulpride

4-week open label amisulpride treatment

Sponsors & Collaborators

  • Glostrup University Hospital, Copenhagen

    collaborator OTHER
  • Rigshospitalet, Denmark

    collaborator OTHER
  • Institute of Psychiatry, London

    collaborator OTHER
  • UMC Utrecht

    collaborator OTHER
  • Copenhagen Hospital Corporation

    collaborator OTHER
  • Birte Glenthoj

    lead OTHER

Principal Investigators

  • Birte Glenthøj, MD, DMSc · Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2016-07-31
Completion
2016-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01555814 on ClinicalTrials.gov