One Year Drug Treatment in First-Episode Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Janssen-Cilag Ltd.
University of Bonn
Humboldt-Universität zu Berlin
University of München
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:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00159081
First received: September 7, 2005
Last updated: February 6, 2008
Last verified: January 2008
  Purpose

Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: Haloperidol, Risperidone (drug)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • relapse rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • course in psychopathology [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • social and cognitive functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • side-effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • drop-out [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: November 2000
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Maintenance antipsychotic treatment with risperidone
Drug: Haloperidol, Risperidone (drug)
targeted dose of 2-4 mg/day over 1 year
Active Comparator: 2
Maintenance antipsychotic treatment with haloperidol in low-dose
Drug: Haloperidol, Risperidone (drug)
targeted dose of 2-4 mg/day over 1 year

Detailed Description:

The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
  • Age between 18 and 55
  • Informed consent

Exclusion Criteria:

  • Residence outside of the catchment area
  • 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: NCT00159081

Locations
Germany
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University
Duesseldorf, North Rhine-Westphalia, Germany, 40629
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Janssen-Cilag Ltd.
University of Bonn
Humboldt-Universität zu Berlin
University of München
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: Wolfgang Gaebel, Professor Department of Psychiatry and Psychotherapy, University of Duesseldorf
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00159081     History of Changes
Other Study ID Numbers: 01GI 9932 - P 2.2.2.1 / 1
Study First Received: September 7, 2005
Last Updated: February 6, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:
Schizophrenia
first episode
long-term treatment
typical vs. atypical neuroleptics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Haloperidol
Haloperidol decanoate
Risperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Antagonists
Serotonin Agents

ClinicalTrials.gov processed this record on October 19, 2014