NCT00224315

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

First QC Date

September 15, 2005

Last Update Submit

June 2, 2008

Conditions

Schizophrenia, Schizoaffective Disorder

Keywords

Schizophrenia,schizoaffective disorder,treatment resistancyclozapine,ziprasidonerisperidonecombination

Outcome Measures

Primary Outcomes (1)

  • PANSS, SANS, HAMD, GAF, CGI, QTc

Secondary Outcomes (1)

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

Interventions

ziprasidoneDRUG
risperidoneDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treatment resistant schizophrenic or schizoaffective disorder under therapy with clozapine,
  • Age between 18 and 70,
  • Informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

ziprasidoneRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mathias Zink, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

November 1, 2003

Study Completion

September 1, 2006

Last Updated

June 4, 2008

Record last verified: 2008-06

Locations

DE(1)