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

Central Institute of Mental Health, Mannheim24 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia, Schizoaffective Disorder

Interventions

ziprasidoneDRUG

risperidoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

PANSS, SANS, HAMD, GAF, CGI, QTc

Secondary Outcomes

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

Data from ClinicalTrials.gov

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