Clozapine-Augmentation With Ziprasidone or Risperidone, a... | NCT00224315

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

NCT00224315

Sponsor

Central Institute of Mental Health, Mannheim

Status

Completed

Last Update Posted

Jun 4, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Schizophrenia, Schizoaffective Disorder

Interventions

ziprasidone
risperidone

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Sep 15, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2008

Last Update Posted Date

Jun 4, 2008Estimated

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PANSS, SANS, HAMD, GAF, CGI, QTc

Secondary Outcomes

Measure	Description	Time Frame
Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathias Zink, MD	Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Institute of Mental Health, Department of Psychiatry,		Mannheim	Baden-Wurttemberg	68159	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C092292	ziprasidone
D018967	Risperidone

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
ziprasidone	Drug
risperidone	Drug