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

Schizophrenia, Schizoaffective Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224315
• Other study ID #: CZR-zink
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2005
• Last updated: June 2, 2008
• Start date: November 2003
• Est. completion date: September 2006

Study information

• Verified date: June 2008
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia
• Schizophrenia, Schizoaffective Disorder

Intervention

Drug:
• ziprasidone

• risperidone

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health, Department of Psychiatry,	Mannheim	BW

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS, SANS, HAMD, GAF, CGI, QTc
Secondary	Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate