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

This study has been completed.
Sponsor:
Information provided by:
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT00224315
First received: September 15, 2005
Last updated: June 2, 2008
Last verified: June 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00224315     History of Changes
Other Study ID Numbers: CZR-zink
Study First Received: September 15, 2005
Last Updated: June 2, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on June 17, 2013