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

June 2, 2008 updated by: Central Institute of Mental Health, Mannheim
We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Mannheim, BW, Germany, 68159
        • Central Institute of Mental Health, Department of Psychiatry,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
PANSS, SANS, HAMD, GAF, CGI, QTc

Secondary Outcome Measures

Outcome Measure
Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Investigators

  • Principal Investigator: Mathias Zink, MD, Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

June 4, 2008

Last Update Submitted That Met QC Criteria

June 2, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZR-zink

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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