Optimization of Treatment and Management of Schizophrenia in Europe

NCT01248195 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2018-05-15

No results posted yet for this study

Summary

The purpose of the study is optimising current treatments in schizophrenia and explore novel therapeutic options for schizophrenia. The study intends to both address basic, but so far unanswered, questions in the treatment of schizophrenia and develop new interventions. It is expected that the project will lead to evidence that is directly applicable to treatment guidelines, and will identify potential mechanisms for new drug development.

Conditions

  • Schizophrenia
  • Schizophreniform Disorder
  • Schizoaffective Disorder

Interventions

DRUG

Amisulpride open label

4-week open label amisulpride treatment

DRUG

6-week amisulpride double blind treatment

6-week amisulpride double blind treatment

DRUG

6-week olanzapine double blind treatment

6-week olanzapine double blind treatment

DRUG

12-week clozapine open-label treatment

12-week clozapine open-label treatment

BEHAVIORAL

Psychosocial intervention

Psychosocial intervention

Sponsors & Collaborators

  • King's College London

    collaborator OTHER
  • Technical University of Munich

    collaborator OTHER
  • University of Manchester

    collaborator OTHER
  • Ludwig-Maximilians - University of Munich

    collaborator OTHER
  • Rene Kahn

    lead OTHER

Principal Investigators

  • René Kahn, MD, PhD · University Medical Center Utrecht, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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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 NCT01248195 on ClinicalTrials.gov