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One Year Drug Treatment in First-Episode Schizophrenia

One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00159081
Enrollment
159
Registered
2005-09-12
Start date
2000-11-30
Completion date
2005-06-30
Last updated
2008-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, first episode, long-term treatment, typical vs. atypical neuroleptics

Brief summary

Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.

Detailed description

The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).

Interventions

DRUGHaloperidol, Risperidone (drug)

targeted dose of 2-4 mg/day over 1 year

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
German Research Network On Schizophrenia
CollaboratorNETWORK
Janssen-Cilag Ltd.
CollaboratorINDUSTRY
University of Bonn
CollaboratorOTHER
Humboldt-Universität zu Berlin
CollaboratorOTHER
University of München
CollaboratorOTHER
University of Göttingen
CollaboratorOTHER
University of Cologne
CollaboratorOTHER
Mainz University
CollaboratorOTHER
University Hospital Tuebingen
CollaboratorOTHER
Universität Duisburg-Essen
CollaboratorOTHER
University of Mannheim
CollaboratorOTHER
University of Jena
CollaboratorOTHER
Martin-Luther-Universität Halle-Wittenberg
CollaboratorOTHER
RWTH Aachen University
CollaboratorOTHER
University of Wuerzburg
CollaboratorOTHER
Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20) * Age between 18 and 55 * Informed consent

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

MeasureTime frame
relapse rate1 year

Secondary

MeasureTime frame
course in psychopathology1 year
social and cognitive functioning1 year
side-effects1 year
drop-out1 year
quality of life1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026