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
  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:


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

ClinicalTrials.gov processed this record on October 23, 2014