Optimization of Acute Treatment in First Episode Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2000 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Active, not recruiting
Sponsor:
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
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00157378
First received: September 8, 2005
Last updated: NA
Last verified: January 2000
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Optimization of Acute Treatment in First Episode Schizophrenic Patients by New Pharmacological Treatments

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

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

Estimated Enrollment: 300
Study Start Date: November 2000
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157378

Locations
Germany
Department of Psychiatry, Ludwig-Maximilians-University
Munich, Germany, 80336
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
Universität Duisburg-Essen
University of Mannheim
University of Jena
Martin-Luther-Universität Halle-Wittenberg
RWTH Aachen University
University of Wuerzburg
Investigators
Study Chair: Hans-Jürgen Möller, Professor Department of Psychiatry, Ludwig-Maximilians-University Munich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157378     History of Changes
Other Study ID Numbers: 01GI9933-P2.1.2.1
Study First Received: September 8, 2005
Last Updated: September 8, 2005
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
first episode,
schizophrenia,
atypical neuroleptics,
negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014