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One Year Drug Treatment in First-Episode Schizophrenia - Article


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Haloperidol Tablets

Haldol Tablets


Clinical Trial: One Year Drug Treatment in First-Episode Schizophrenia

This study is no longer recruiting patients.

Sponsors and Collaborators: Heinrich-Heine University, Duesseldorf
Federal Ministry of Education and Research
German Research Network on Schizophrenia
Janssen-Cilag
Departments of Psychiatry, Universities of Bonn, Berlin, München, Göttingen, Cologne, Mainz, Tübingen, Essen, Mannheim, Jena, Halle, Aachen, Würzburg
Information provided by: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT00159081

Purpose

The study involves a prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone).
Condition Intervention Phase
Schizophrenia
  Drug: Haloperidol, Risperidone (drug)
 Phase IV

MedlinePlus related topics:  Schizophrenia

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

Official Title: One Year Maintenance Treatment with Low Dose Haloperidol Vs. Risperidone in First-Episode Schizophrenia

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:  159

Study start: November 2000;  Study completion: December 2005
Last follow-up: April 2005;  Data entry closure: September 2005

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).

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

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
      Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University, Duesseldorf,  North Rhine-Westphalia,  40629,  Germany

Study chairs or principal investigators

Wolfgang Gaebel, Professor,  Study Chair,  Department of Psychiatry and Psychotherapy, University of Duesseldorf   

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 2.2.2.1 / 1
Last Updated:  September 11, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00159081
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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November 18, 2008


Page Updated: June 1, 2005
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