Optimization of Acute Treatment in First Episode Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia, First-Episode

Keywords

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first episode, schizophrenia, atypical neuroleptics, negative symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Risperidone, Haloperidol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Hans-Jürgen Möller, Professor

Role: STUDY_CHAIR

Department of Psychiatry, Ludwig-Maximilians-University Munich

Locations

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Department of Psychiatry, Ludwig-Maximilians-University

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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01GI9933-P2.1.2.1

Identifier Type: -

Identifier Source: org_study_id

Optimization of Acute Treatment in First Episode Schizophrenia

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Risperidone, Haloperidol

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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

Ludwig-Maximilians - University of Munich