One Year Drug Treatment in First-Episode Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Haloperidol, Risperidone (drug)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, first episode, long-term treatment, typical vs. atypical neuroleptics
Eligibility Criteria
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
Sites / Locations
- Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Maintenance antipsychotic treatment with risperidone
Maintenance antipsychotic treatment with haloperidol in low-dose
Outcomes
Primary Outcome Measures
relapse rate
Secondary Outcome Measures
course in psychopathology
social and cognitive functioning
side-effects
drop-out
quality of life
Full Information
NCT ID
NCT00159081
First Posted
September 7, 2005
Last Updated
February 6, 2008
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
1. Study Identification
Unique Protocol Identification Number
NCT00159081
Brief Title
One Year Drug Treatment in First-Episode Schizophrenia
Official Title
One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the 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
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, first episode, long-term treatment, typical vs. atypical neuroleptics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Maintenance antipsychotic treatment with risperidone
Arm Title
2
Arm Type
Active Comparator
Arm Description
Maintenance antipsychotic treatment with haloperidol in low-dose
Intervention Type
Drug
Intervention Name(s)
Haloperidol, Risperidone (drug)
Intervention Description
targeted dose of 2-4 mg/day over 1 year
Primary Outcome Measure Information:
Title
relapse rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
course in psychopathology
Time Frame
1 year
Title
social and cognitive functioning
Time Frame
1 year
Title
side-effects
Time Frame
1 year
Title
drop-out
Time Frame
1 year
Title
quality of life
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Gaebel, Professor
Organizational Affiliation
Department of Psychiatry and Psychotherapy, University of Duesseldorf
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University
City
Duesseldorf
State/Province
North Rhine-Westphalia
ZIP/Postal Code
40629
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
15146342
Citation
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.
Results Reference
background
PubMed Identifier
18052570
Citation
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.
Results Reference
result
Links:
URL
http://www.kompetenznetz-schizophrenie.de
Description
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One Year Drug Treatment in First-Episode Schizophrenia
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