Back to resultsClozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ziprasidone
risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia, Schizoaffective Disorder focused on measuring Schizophrenia,, schizoaffective disorder,, treatment resistancy, clozapine,, ziprasidone, risperidone, combination
Eligibility 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)
Sites / Locations
- Central Institute of Mental Health, Department of Psychiatry,
Outcomes
Primary Outcome Measures
PANSS, SANS, HAMD, GAF, CGI, QTc
Secondary Outcome Measures
Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate
Full Information
NCT ID
NCT00224315
First Posted
September 15, 2005
Last Updated
June 2, 2008
Sponsor
Central Institute of Mental Health, Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT00224315
Brief Title
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
Official Title
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Central Institute of Mental Health, Mannheim
4. Oversight
5. Study Description
Brief Summary
We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia,, schizoaffective disorder,, treatment resistancy, clozapine,, ziprasidone, risperidone, combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ziprasidone
Intervention Type
Drug
Intervention Name(s)
risperidone
Primary Outcome Measure Information:
Title
PANSS, SANS, HAMD, GAF, CGI, QTc
Secondary Outcome Measure Information:
Title
Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Zink, MD
Organizational Affiliation
Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Institute of Mental Health, Department of Psychiatry,
City
Mannheim
State/Province
BW
ZIP/Postal Code
68159
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
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