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

• Sponsor: Central Institute of Mental Health, Mannheim (Other)
• Overall Status: Completed
• CT.gov ID: NCT00224315
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 34
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia, Schizoaffective Disorder	Drug: ziprasidone; Drug: risperidone	Phase 4

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 Design

• Study Type: Interventional
• 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
• Study Start Date: Nov 1, 2003
• Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. PANSS, SANS, HAMD, GAF, CGI, QTc []

Secondary Outcome Measures

1. Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00224315
• Other Study ID Numbers: CZR-zink
• First Posted: Sep 22, 2005
• Last Update Posted: Jun 4, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Schizophrenia,; schizoaffective disorder,; treatment resistancy; clozapine,; ziprasidone; risperidone; combination
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders; Risperidone; Ziprasidone

Study Results

No Results Posted as of Jun 4, 2008