Psychoses, Schizophrenia
Conditions
Keywords
Schizophrenia, first episode, neuroleptic maintenance treatment, drug discontinuation, prodrome based early intervention
Brief summary
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.
Detailed description
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied.
Interventions
OTHERmaintained antipsychotic treatment vs. stepwise drug discontinuation
maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year
Sponsors
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Janssen-Cilag Ltd.
University of Bonn
Humboldt-Universität zu Berlin
Ludwig-Maximilians - University of Munich
University of Göttingen
University of Cologne
Mainz University
University Hospital Tuebingen
Universität Duisburg-Essen
University of Mannheim
University of Jena
Martin-Luther-Universität Halle-Wittenberg
RWTH Aachen University
University of Wuerzburg
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20) * Age between 18 and 55 * Informed consent * One year neuroleptic maintenance treatment * Reaching stable course
Exclusion criteria
* Residence outside of the catchment area * Legal reasons * Insufficient knowledge of the german language * Substance abuse or addiction * Pregnancy * Serious physical illness * Organic brain disease * Contraindication to neuroleptic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse rate | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| psychopathology | 1 year |
| social and cognitive functioning | 1 year |
| side-effects | 1 year |
| drop-out | 1 year |
| quality of life | 1 year |
Countries
Germany
Outcome results
None listed