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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Schizophrenia, Schizoaffective Disorder

Keywords

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Schizophrenia, schizoaffective disorder, treatment resistancy clozapine, ziprasidone risperidone combination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ziprasidone

Intervention Type DRUG

risperidone

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Mathias Zink, MD

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany

Locations

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Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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CZR-zink

Identifier Type: -

Identifier Source: org_study_id