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

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.

Conditions

• Schizophrenia
• Psychoses

Interventions

DRUG

antipsychotics 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 & Collaborators

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• German Research Network On Schizophrenia

  collaborator NETWORK

• Janssen-Cilag Ltd.

  collaborator INDUSTRY

• University of Bonn

  collaborator OTHER

• Humboldt-Universität zu Berlin

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University of Göttingen

  collaborator OTHER

• University of Cologne

  collaborator OTHER

• Mainz University

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• Universität Duisburg-Essen

  collaborator OTHER

• University of Mannheim

  collaborator OTHER

• University of Jena

  collaborator OTHER

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• RWTH Aachen University

  collaborator OTHER

• University of Wuerzburg

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  lead OTHER

Principal Investigators

• Wolfgang Gaebel, Professor · Department of Psychiatry and Psychotherapy, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-11-30

Primary Completion

2006-06-30

Completion

2006-06-30

Countries

• Germany

Study Locations