Schizophrenia, Schizoaffective DisorderPhase 4NCT00224315
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
A Phase 4 study testing ziprasidone and risperidone in people with Schizophrenia, Schizoaffective Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- ziprasidone and risperidone
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2003to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment resistant schizophrenic or schizoaffective disorder under therapy with clozapine,
- Age between 18 and 70,
- Informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Central Institute of Mental Health, Department of Psychiatry,
Mannheim, Baden-Wurttemberg, 68159
About this study
We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- ziprasidone, risperidone
- Keywords
- Schizophrenia,, schizoaffective disorder,, treatment resistancy, clozapine,, ziprasidone, risperidone, combination
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidoneDrug
risperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS, SANS, HAMD, GAF, CGI, QTc
Secondary outcomes (1)
Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia, Schizoaffective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Investigators
- Mathias Zink, MD, Principal investigator, Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224315
- Sponsor's protocol ID
- CZR-zink
- Status last verified
- Jun 2008
- First submitted
- 15 Sep 2005
- Last updated
- 4 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
- ClinicalTrials.gov ID
- NCT00224315
- Acronym / sponsor ID
- CZR-zink
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia,, schizoaffective disorder,, treatment resistancy, clozapine,, ziprasidone, risperidone, combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- Nov 2003
- Study completion
- Sep 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Treatment resistant schizophrenic or schizoaffective disorder under therapy with clozapine,
- Age between 18 and 70,
- Informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ziprasidone | Drug | – |
| risperidone | Drug | – |
Primary outcome
PANSS, SANS, HAMD, GAF, CGI, QTc
1 secondary outcome
Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Zink, MD principal investigator
Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ziprasidone and risperidone in people with Schizophrenia, Schizoaffective Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS, SANS, HAMD, GAF, CGI, QTc. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2008; AzTrials last refreshed its copy on 3 Nov 2026.