One Year Drug Treatment in First-Episode Schizophrenia
This study has been completed.
Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborators:
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Janssen-Cilag Ltd.
University Hospital, 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
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00159081
First received: September 7, 2005
Last updated: February 6, 2008
Last verified: January 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Haloperidol, Risperidone (drug) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Heinrich-Heine University, Duesseldorf:
Primary Outcome Measures:
- relapse rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- course in psychopathology [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- social and cognitive functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- side-effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- drop-out [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 159 |
| Study Start Date: | November 2000 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159081
Locations
| Germany | |
| 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 Hospital, 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
Investigators
| Study Chair: | Wolfgang Gaebel, Professor | Department of Psychiatry and Psychotherapy, University of Duesseldorf |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00159081 History of Changes |
| Other Study ID Numbers: | 01GI 9932 - P 2.2.2.1 / 1 |
| Study First Received: | September 7, 2005 |
| Last Updated: | February 6, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Heinrich-Heine University, Duesseldorf:
|
Schizophrenia first episode long-term treatment typical vs. atypical neuroleptics |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Haloperidol Haloperidol decanoate Risperidone Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Serotonin Antagonists Serotonin Agents |
ClinicalTrials.gov processed this record on May 19, 2013