FindTrial
Sign In

Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia

Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepine in Patients With First-Episode Schizophrenia After One Year Maintenance Treatment Under Further Maintenance Treatment vs. Stepwise Discontinued Drugs

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00159133
Enrollment
71
Registered
2005-09-12
Start date
2001-11-30
Completion date
2006-06-30
Last updated
2008-01-30

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

Conditions

Psychoses, Schizophrenia

Keywords

Schizophrenia, first episode, prodrome based early intervention, antipsychotics - benzodiazepine, maintenance treatment, drug discontinuation

Brief summary

Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.

Detailed description

In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after stepwise drug discontinuation.

Interventions

DRUGantipsychotics vs. Lorazepam (Drugs)

Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;

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
Ludwig-Maximilians - University of Munich
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

* First-episode in schizophrenia (according ICD-10 F20) * Age between 18 and 55 * Informed consent * One year neuroleptic maintenance treatment

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
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: Feb 4, 2026