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

Central Institute of Mental Health, Mannheim

Status and phase: Completed; Phase 4

Conditions: Schizophrenia, Schizoaffective Disorder

Treatments: Drug: ziprasidone; Drug: risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT00224315

CZR-zink

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)