Optimization of Acute Treatment in First Episode Schizophrenia

Schizophrenia, First-Episode Clinical Trial

Official title:

Optimization of Acute Treatment in First Episode Schizophrenic Patients by New Pharmacological Treatments

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00157378
• Other study ID #: 01GI9933-P2.1.2.1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: September 8, 2005
• Start date: November 2000
• Est. completion date: December 2004

Study information

• Verified date: January 2000
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia, First-Episode

Intervention

Drug:
• Risperidone, Haloperidol

Locations

Country	Name	City	State
Germany	Department of Psychiatry, Ludwig-Maximilians-University	Munich

Sponsors (16)

Lead Sponsor

Collaborator

Ludwig-Maximilians - University of Munich

Department of Psychiatry University FU Berlin, Department of Psychiatry University of Bonn, German Research Network On Schizophrenia, Heinrich-Heine University, Duesseldorf, Janssen-Cilag Ltd., Mainz University, Martin-Luther-Universität Halle-Wittenberg, RWTH Aachen University, Universität Duisburg-Essen, University Hospital Tuebingen, University of Cologne, University of Göttingen, University of Jena, University of Mannheim, University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weekly assessment of psychopathology (e.g.PANSS)and side-effects
Secondary	cognitive disability
Secondary	depression
Secondary	life quality at time of admission & end of study

External Links

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