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Prodrome-Based Early Intervention with Antipsychotics Vs. Benzodiazepines in First-Episode Schizophrenia - Article


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Clinical Trial: Prodrome-Based Early Intervention with Antipsychotics Vs. Benzodiazepines in First-Episode Schizophrenia

This study is no longer recruiting patients.

Sponsors and Collaborators: Heinrich-Heine University, Duesseldorf
Federal Ministry of Education and Research, Germany
German Research Network on Schizophrenia
Janssen-Cilag
Departments of Psychiatry, Universities of Bonn, Berlin, Munich, Göttingen, Cologne, Mainz, Tübingen, Essen, Mannheim, Jena, Halle, Aachen, Würzburg
Information provided by: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT00159133

Purpose

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.
Condition Intervention Phase
Schizophrenia
Psychoses
  Drug: Haloperidol, Risperidone, Lorazepam (Drugs)
 Phase IV

MedlinePlus related topics:  Mental Health;   Schizophrenia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official 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

Further Study Details: 
Primary Outcomes: 1 year relapse rate
Secondary Outcomes: 1 year course regarding psychopathology; social and cognitive functioning; side-effects; drop-out; quality of life
Expected Total Enrollment:  71

Study start: November 2001;  Study completion: December 2006
Last follow-up: April 2006;  Data entry closure: September 2006

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.

Eligibility

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both
Criteria

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

Location Information


Germany, North Rhine-Westphalia
      German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Düsseldorf,  North Rhine-Westphalia,  40629,  Germany

Study chairs or principal investigators

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

More Information

Publications

Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S. Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004 Apr;254(2):129-40.

Study ID Numbers:  01GI 9932 – P 2.2.2.2
Last Updated:  September 11, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00159133
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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Page Updated: June 1, 2005
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