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CompletedNCT00159081Updated Feb 7, 2008

One Year Drug Treatment in First-Episode Schizophrenia

A Phase 4 interventional study of Haloperidol, Risperidone (drug) in Schizophrenia, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2008-02-07.

Sponsored by Heinrich-Heine University, Duesseldorf · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study summary

Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.

Read the detailed description

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).

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Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia
  • first episode
  • long-term treatment
  • typical vs. atypical neuroleptics
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 159 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
  • Age between 18 and 55
  • Informed consent

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
159 participants (actual)

Study arms

  • Experimental
    1

    Maintenance antipsychotic treatment with risperidone

    Drug: Haloperidol, Risperidone (drug)

  • Active comparator
    2

    Maintenance antipsychotic treatment with haloperidol in low-dose

    Drug: Haloperidol, Risperidone (drug)

Interventions

  • DrugHaloperidol, Risperidone (drug)

    targeted dose of 2-4 mg/day over 1 year

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What researchers measure

Primary outcomes

  1. relapse rate

    Time frame: 1 year

Secondary outcomes

  1. course in 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

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Study locations

1 site
  • Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University
    Duesseldorf, North Rhine-Westphalia 40629, Germany
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References and documents

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. doi: 10.1007/s00406-004-0509-y. PubMed 15146342 ↗
  • Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Jockers-Scherubl MC, Kuhn KU, Lemke M, Bechdolf A, Bender S, Degner D, Schlosser R, Schmidt LG, Schmitt A, Jager M, Buchkremer G, Falkai P, Klingberg S, Kopcke W, Maier W, Hafner H, Ohmann C, Salize HJ, Schneider F, Moller HJ; German Study Group on First-Episode Schizophrenia. Maintenance treatment with risperidone or low-dose haloperidol in first-episode schizophrenia: 1-year results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2007 Nov;68(11):1763-74. doi: 10.4088/jcp.v68n1116. PubMed 18052570 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00159081
Lead sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Janssen-Cilag Ltd., University of Bonn, Humboldt-Universität zu Berlin, University of München, University of Göttingen, University of Cologne, Mainz University, University Hospital Tuebingen, Universität Duisburg-Essen, University of Mannheim, University of Jena, Martin-Luther-Universität Halle-Wittenberg, RWTH Aachen University, University of Wuerzburg
First posted
Sep 12, 2005
Start date
Nov 2000
Primary completion
Jun 2005
Completion
Jun 2005
Last update
Feb 7, 2008

Study contacts

Wolfgang Gaebel, Professor
study chair · Department of Psychiatry and Psychotherapy, University of Duesseldorf

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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