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| Sponsors and Collaborators: |
Ludwig-Maximilians - University of Munich Janssen-Cilag Ltd. German Research Network On Schizophrenia Department of Psychiatry University of Bonn Heinrich-Heine University, Duesseldorf Department of Psychiatry University FU Berlin University of Göttingen University of Cologne Mainz University University Hospital Tuebingen Univeristat Duisburg-Essen University of Mannheim University of Jena Martin-Luther-Universität Halle-Wittenberg RWTH Aachen University University of Wuerzburg |
|---|---|
| Information provided by: | Ludwig-Maximilians - University of Munich |
| ClinicalTrials.gov Identifier: | NCT00157378 |
Purpose
The study is a multicenter, double-blind, randomized, parallel-group study with first episode schizophrenic patients. During a treatment phase of 8 weeks the patients are treated with Risperidone or Haloperidol. Aim of the project is to compare the effects of the atypical neuroleptic Risperidone with those of the conventional neuroleptic Haloperidol and to evaluate whether the assumed advantages of atypical neuroleptics compared to conventional neuroleptics are also present when both medications are administered in rather low daily dosages (min. 2 mg/d; max. 8 mg/d).
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia, First-Episode |
Drug: Risperidone, Haloperidol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Optimization of Acute Treatment in First Episode Schizophrenic Patients by New Pharmacological Treatments |
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2000 |
| Estimated Study Completion Date: | December 2004 |
Considering that first episode schizophrenic patients compared to multiple episode patients respond to lower dosages of neuroleptics, the study aims to reach neuroleptic response under the lowest possible dosage of the study medication (haloperidol or risperidone). Therefore the initial dosage of the study medication is 2 mg/d. Depending on the patients` symptomatology, the daily dosage of the study medication can be increased by 2 mg in weekly intervals up to a maximum dosage of 8 mg/d. Patients with the diagnosis of schizophrenia (F20, according to ICD-10-criteria) are consecutively enrolled in the study. The patients are assessed at weekly intervals during the acute inpatient treatment phase of 8 weeks. Apart from the weekly psychopathological characterisation additionally neuropsychobiological data are assessed at the time of admission and at the end of the study. Major questions of the study are, whether patients, who have been treated with risperidone compared with those, who have been treated with haloperidol show a better treatment outcome regarding negative symptoms and exhibit fewer extra-pyramidal motor side effects. Furthermore it is hypothesised, that the treatment with Risperidone has better effects on cognitive disorders/dysfunctions and depressive symptoms and that the patients, who receive Risperidone are more compliant and have a higher quality of life.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Department of Psychiatry, Ludwig-Maximilians-University | |
| Munich, Germany, 80336 | |
| Study Chair: | Hans-Jürgen Möller, Professor | Department of Psychiatry, Ludwig-Maximilians-University Munich |
More Information
| Study ID Numbers: | 01GI9933-P2.1.2.1 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 8, 2005 |
| ClinicalTrials.gov Identifier: | NCT00157378 |
| Health Authority: | Germany: Ethics Commission |
|
first episode, schizophrenia, atypical neuroleptics, negative symptoms |
|
Haloperidol Schizophrenia Haloperidol decanoate Dopamine Mental Disorders |
Risperidone Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
