One Year Drug Treatment in First-Episode Schizophrenia
Information source: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Haloperidol, Risperidone (drug) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Heinrich-Heine University, Duesseldorf Official(s) and/or principal investigator(s): Wolfgang Gaebel, Professor, Study Chair, Affiliation: Department of Psychiatry and Psychotherapy, University of Duesseldorf
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.
Clinical Details
Official title: One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: relapse rate
Secondary outcome: course in psychopathologysocial and cognitive functioning side-effects drop-out quality of life
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University, Duesseldorf, North Rhine-Westphalia 40629, Germany
Additional Information
Click here for more information about this study: One year maintenance treatment with low dose Haloperidol vs. Risperidone in first-episode schizophrenia
Related publications: Gaebel W, Möller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wölwer 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.
Starting date: November 2000
Last updated: February 6, 2008
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