SchizophreniaPhase 4NCT00048828
Treating Drug-Resistant Childhood Schizophrenia
A Phase 4 study testing Olanzapine and Clozapine in people with Schizophrenia, run by Northwell Health at 3 sites in United States.
Trial summary
This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine and Clozapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2001to Jun 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- DSM-IV criteria for treatment-refractory schizophrenia or schizoaffective disorder
- Willingness to use an acceptable form of birth control, if applicable
Who cannot join
- Neurological or medical disorders that would contraindicate treatment with clozapine or olanzapine
- IQ less than 70
- DSM-IV criteria for substance (other than caffeine or nicotine) related disorder
- Failure of an adequate trial of olanzapine or clozapine
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sagamore Children's Psychiatric Center
Dix Hills, New York, 11746
Long Island Jewish Medical Center
Glen Oaks, New York, 11004
Bronx Children's Psychiatric Center
The Bronx, New York, 10461
About this study
Official title: Treating Refractory Childhood Schizophrenia
This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.
Read the detailed description
Schizophrenia is a devastating illness regardless of the age at which it presents. When this disorder occurs in childhood or adolescence, the consequences in terms of functional impairment, loss of developmental opportunities, and family and societal burden are particularly dramatic.
Evidence supports the improved efficacy and/or side effect profile of atypical antipsychotic medication in adults. Thus, it is essential to examine whether the potential benefits of these agents can be extended to children, particularly children who have failed standard treatment.
Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks. Patients meet with the study team once a week to discuss progress and record side effects. Three parent meetings take place during the study. During these meetings, questions are discussed and support and education about schizophrenia are given to parents. Various scales to measure psychotic, manic, aggressive, and depressive symptoms are used to assess patients.
- Conditions
- Schizophrenia
- Being tested
- Olanzapine, Clozapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Participants will receive olanzapine for 12 weeks.
ClozapineDrug
Participants will receive 12 weeks of clozapine.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Olanzapine |
| 2 | Active comparator | Not described Receives: Drug: Clozapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotic, manic, aggressive, and depressive symptoms
Measured: Measured over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2002 (estimated)
- Study startOct 2001
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Christoph U. Correll, MD, Principal investigator, The Zucker Hillside Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048828
- Sponsor's protocol ID
- R01MH060229
- Other IDs
- R01MH060229, DSIR 84-CTM
- Status last verified
- Jul 2013
- First submitted
- 8 Nov 2002
- Last updated
- 2 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Refractory Childhood Schizophrenia
- ClinicalTrials.gov ID
- NCT00048828
- Acronym / sponsor ID
- R01MH060229
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 13 Nov 2002 (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.
This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.
Detailed description
Schizophrenia is a devastating illness regardless of the age at which it presents. When this disorder occurs in childhood or adolescence, the consequences in terms of functional impairment, loss of developmental opportunities, and family and societal burden are particularly dramatic.
Evidence supports the improved efficacy and/or side effect profile of atypical antipsychotic medication in adults. Thus, it is essential to examine whether the potential benefits of these agents can be extended to children, particularly children who have failed standard treatment.
Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks. Patients meet with the study team once a week to discuss progress and record side effects. Three parent meetings take place during the study. During these meetings, questions are discussed and support and education about schizophrenia are given to parents. Various scales to measure psychotic, manic, aggressive, and depressive symptoms are used to assess patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Olanzapine |
| 2 | Active comparator | Drug: Clozapine |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- DSM-IV criteria for treatment-refractory schizophrenia or schizoaffective disorder
- Willingness to use an acceptable form of birth control, if applicable
Key exclusion criteria (4 listed)
- Neurological or medical disorders that would contraindicate treatment with clozapine or olanzapine
- IQ less than 70
- DSM-IV criteria for substance (other than caffeine or nicotine) related disorder
- Failure of an adequate trial of olanzapine or clozapine
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 |
|---|---|---|
| OlanzapineParticipants will receive olanzapine for 12 weeks. | Drug | 1 |
| ClozapineParticipants will receive 12 weeks of clozapine. | Drug | 2 |
Primary outcome
Psychotic, manic, aggressive, and depressive symptoms
Time frame: Measured over 12 weeks
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 2 Jul 2013.
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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.
Christoph U. Correll, MD principal investigator
The Zucker Hillside Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine and Clozapine in people with Schizophrenia, run by Northwell Health at 3 sites in United States.
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 2 inclusion and 4 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 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Psychotic, manic, aggressive, and depressive symptoms (time frame: Measured over 12 weeks). 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 2 Jul 2013.