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OpenTrials
Completed

NCT Number: NCT00224315

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

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

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Key information

Conditions

Schizophrenia, Schizoaffective Disorder Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, 68159, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ziprasidone

Drug

Risperidone

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Important dates

Study start
2003
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Jun 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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