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Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00224315
First Posted: September 22, 2005
Last Update Posted: June 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Central Institute of Mental Health, Mannheim
  Purpose
We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.

Condition Intervention Phase
Schizophrenia, Schizoaffective Disorder Drug: ziprasidone Drug: risperidone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial

Resource links provided by NLM:


Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:
  • PANSS, SANS, HAMD, GAF, CGI, QTc

Secondary Outcome Measures:
  • Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate

Estimated Enrollment: 24
Study Start Date: November 2003
Estimated Study Completion Date: September 2006
Detailed Description:
Partial response of schizophrenic psychoses to a monotherapy with clozapine is a frequent problem of clinical psychiatry. Current problems are treatment resistant positive and/or negative symptoms, as well as side effects. Therefore, different strategies of augmentations have been applied. Based on successful experiences in case reports and results of other work groups, we aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment resistant schizophrenic or schizoaffective disorder under therapy with clozapine,
  • Age between 18 and 70,
  • Informed consent

Exclusion Criteria:

  • No informed consent,
  • Intolerance with respect to ziprasidone or risperidone,
  • Contraindications with respect to these substances,
  • Gravidity or missing anticonceptive safety
  • Substance dependance (excluded nicotin)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224315


Locations
Germany
Central Institute of Mental Health, Department of Psychiatry,
Mannheim, BW, Germany, 68159
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Investigators
Principal Investigator: Mathias Zink, MD Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00224315     History of Changes
Other Study ID Numbers: CZR-zink
First Submitted: September 15, 2005
First Posted: September 22, 2005
Last Update Posted: June 4, 2008
Last Verified: June 2008

Keywords provided by Central Institute of Mental Health, Mannheim:
Schizophrenia,
schizoaffective disorder,
treatment resistancy
clozapine,
ziprasidone
risperidone
combination

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Ziprasidone
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
GABA Antagonists
GABA Agents