Skip to main content
OpenTrials
Completed

NCT Number: NCT00159133

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Psychoses Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40629, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antipsychotics vs. Lorazepam (Drugs)

Drug

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

Primary outcomes

  1. relapse rate

    Time frame: 1 year

Secondary outcomes

  1. psychopathology

    Time frame: 1 year

  2. social and cognitive functioning

    Time frame: 1 year

  3. side-effects

    Time frame: 1 year

  4. drop-out

    Time frame: 1 year

  5. quality of life

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • German Federal Ministry of Education and Research
  • German Research Network On Schizophrenia
  • Humboldt-Universität zu Berlin
  • Janssen-Cilag Ltd.
  • Ludwig-Maximilians - University of Munich
  • Mainz University
  • Martin-Luther-Universität Halle-Wittenberg
  • RWTH Aachen University
  • University Hospital Tuebingen
  • University of Bonn
  • University of Cologne
  • University of Göttingen
  • University of Jena
  • University of Mannheim
  • University of Wuerzburg
  • Universität Duisburg-Essen

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Jan 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.