Optimization of Acute Treatment in First Episode Schizophrenia
Primary Purpose
Schizophrenia, First-Episode
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Risperidone, Haloperidol
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia, First-Episode focused on measuring first episode,, schizophrenia,, atypical neuroleptics,, negative symptoms
Eligibility Criteria
Inclusion Criteria: ICD-10 criteria for first episode schizophrenia age between 18 and 55 informed consent Exclusion Criteria: 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, Ludwig-Maximilians-University
Outcomes
Primary Outcome Measures
weekly assessment of psychopathology (e.g.PANSS)and side-effects
Secondary Outcome Measures
cognitive disability
depression
life quality at time of admission & end of study
Full Information
NCT ID
NCT00157378
First Posted
September 8, 2005
Last Updated
September 8, 2005
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
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, 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
NCT00157378
Brief Title
Optimization of Acute Treatment in First Episode Schizophrenia
Official Title
Optimization of Acute Treatment in First Episode Schizophrenic Patients by New Pharmacological Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
January 2000
Overall Recruitment Status
Unknown status
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
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, Universität Duisburg-Essen, University of Mannheim, University of Jena, Martin-Luther-Universität Halle-Wittenberg, RWTH Aachen University, University of Wuerzburg
4. Oversight
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, First-Episode
Keywords
first episode,, schizophrenia,, atypical neuroleptics,, negative symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risperidone, Haloperidol
Primary Outcome Measure Information:
Title
weekly assessment of psychopathology (e.g.PANSS)and side-effects
Secondary Outcome Measure Information:
Title
cognitive disability
Title
depression
Title
life quality at time of admission & end of study
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:
ICD-10 criteria for first episode schizophrenia
age between 18 and 55
informed consent
Exclusion Criteria:
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
Hans-Jürgen Möller, Professor
Organizational Affiliation
Department of Psychiatry, Ludwig-Maximilians-University Munich
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry, Ludwig-Maximilians-University
City
Munich
ZIP/Postal Code
80336
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.kompetenznetz-schizophrenie.de/rdkns/325.htm
Description
Related Info
Learn more about this trial
Optimization of Acute Treatment in First Episode Schizophrenia
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