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One Year Drug Treatment in First-Episode Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00159081
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 7, 2008
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Haloperidol, Risperidone (drug) Phase 4

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia
Study Start Date : November 2000
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Maintenance antipsychotic treatment with risperidone
Drug: Haloperidol, Risperidone (drug)
targeted dose of 2-4 mg/day over 1 year
Active Comparator: 2
Maintenance antipsychotic treatment with haloperidol in low-dose
Drug: Haloperidol, Risperidone (drug)
targeted dose of 2-4 mg/day over 1 year

Outcome Measures

Primary Outcome Measures :
  1. relapse rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159081

Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University
Duesseldorf, North Rhine-Westphalia, Germany, 40629
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
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
Study Chair: Wolfgang Gaebel, Professor Department of Psychiatry and Psychotherapy, University of Duesseldorf
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00159081     History of Changes
Other Study ID Numbers: 01GI 9932 - P / 1
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 7, 2008
Last Verified: January 2008

Keywords provided by Heinrich-Heine University, Duesseldorf:
first episode
long-term treatment
typical vs. atypical neuroleptics

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol decanoate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Dyskinesia Agents