Clinical trial NCT00159081: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
first episode
long-term treatment
typical vs. atypical neuroleptics
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: German Research Network On Schizophrenia
name: Janssen-Cilag Ltd.
name: University of Bonn
name: Humboldt-Universität zu Berlin
name: University of München
name: University of Göttingen
name: University of Cologne
name: Mainz University
name: University Hospital Tuebingen
name: Universität Duisburg-Essen
name: University of Mannheim
name: University of Jena
name: Martin-Luther-Universität Halle-Wittenberg
name: RWTH Aachen University
name: University of Wuerzburg
First posted: 2005-09-12
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: relapse rate
timeFrame: 1 year
Secondary outcomes:
measure: course in psychopathology
timeFrame: 1 year
measure: social and cognitive functioning
timeFrame: 1 year
measure: side-effects
timeFrame: 1 year
measure: drop-out
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Psychiatry and Psychotherapy, University of Duesseldorf
name: Wolfgang Gaebel, Professor
role: STUDY_CHAIR
References:
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.
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.