SchizophreniaNCT00179231
Olanzapine Versus Clozapine in Treatment Refractory Schizophrenia
A study testing olanzapine vs. clozapine in people with Schizophrenia and Schizoaffective Disorder, run by Vanderbilt University.
Trial summary
The study involves a six-month, double-blind protocol during which eighty patients, across three sites around the country, will be randomly assigned to receive clozapine or olanzapine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- olanzapine vs. clozapine
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Feb 2004
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be males and females, ages 18-60, with a definite diagnosis by DSM-IV criteria of schizophrenia (any subtype) or schizoaffective disorder.
- 2) All participants will be refractory according to the Kane et al (1988) criteria, with modification on the number of drug trials to at least two neuroleptic drugs at adequate doses for periods > 3 months. The criteria of Kane et al. for treatment resistance are as follows: three or more trials with antipsychotic drugs of adequate dose and duration (this is usually 4-6 weeks). The original criteria involved three types of typical neuroleptic drugs. Now, it can include any antipsychotic drug other than clozapine. Olanzapine may have been tried but the dose must not have exceeded 30 mg/day.
- Subjects must have a PANNS-derived BPRS total score > 24 (0-6 scale) or BPRS positive subscale item score > 3 on at least two of the four items.
- Participants will be in generally good and stable physical health.
- Written informed consent will be obtained from all participants after a full explanation of the study and procedures. For those patients with a legal guardian, written informed consent will be obtained from the guardian, with verbal assent by the research subject.
- Since both clozapine and olanzapine are approved agents, no specific birth control will be required for females, but advice about birth control will be provided
Who cannot join
- Uncontrolled diabetes or hypertension.
- Cardiac conduction abnormality or uncontrolled arrhythmia.
- History of any blood dyscrasia, including leukemia.
- Significant active hepatic or renal disease, including chronic hepatitis.
- Clinically significant neurological disorder, including (but not limited to) Parkinson's disease, multiple sclerosis, seizure disorder, intracranial mass lesion (note that the presence of tardive dyskinesia is not an exclusion for participants).
- Active cancer with or without chemotherapy within the last five years (not to include a completely excised basal cell carcinoma).
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- Active endocrinological disorder (which does not include adequately treated hypothyroidism).
- Pregnancy or lactation.
- An active substance use disorder within the last six months.
- History of lack of response to an adequate trial of monotherapy with either clozapine or olanzapine in which the dose of clozapine must be > 600 mg/day or the dose of olanzapine must be > 20 mg/day; and the duration of treatment with either must be > 6 weeks.
- History of intolerance of clozapine or olanzapine, including blood dyscrasia
About this study
The study involves a six-month, double-blind protocol during which eighty patients, across three sites around the country, will be randomly assigned to receive clozapine or olanzapine. The specific aims of the study are to evaluate the relative effects of olanzapine and clozapine on clinical outcomes and cognition in patients diagnosed with schizophrenia or schizoaffective disorder who have demonstrated resistance to treatment in the past.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- olanzapine vs. clozapine
- 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.
olanzapine vs. clozapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
There has not been an adequate of test of whether olanzapine is as effective as clozapine in treatment
resistant patients. Several recent studies suggest olanzapine may be effective in some clozapine responders as well as in treatment resistant patients. A head to head comparison is needed to clarify the relative efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2000
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Herbert Y Meltzer, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179231
- Sponsor's protocol ID
- 990172
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Publications
Meltzer HY, Bobo WV, Roy A, Jayathilake K, Chen Y, Ertugrul A, Anil Yagcioglu AE, Small JG. A randomized, double-blind comparison of clozapine and high-dose olanzapine in treatment-resistant patients with schizophrenia. J Clin Psychiatry. 2008 Feb;69(2):274-85. doi: 10.4088/jcp.v69n0214.
PubMed 18232726
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine Versus Clozapine in Treatment Refractory Schizophrenia
- ClinicalTrials.gov ID
- NCT00179231
- Acronym / sponsor ID
- 990172
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 2000
- Study completion
- Feb 2004
- First posted
- 15 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.
The study involves a six-month, double-blind protocol during which eighty patients, across three sites around the country, will be randomly assigned to receive clozapine or olanzapine. The specific aims of the study are to evaluate the relative effects of olanzapine and clozapine on clinical outcomes and cognition in patients diagnosed with schizophrenia or schizoaffective disorder who have demonstrated resistance to treatment in the past.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients will be males and females, ages 18-60, with a definite diagnosis by DSM-IV criteria of schizophrenia (any subtype) or schizoaffective disorder.
- 2) All participants will be refractory according to the Kane et al (1988) criteria, with modification on the number of drug trials to at least two neuroleptic drugs at adequate doses for periods > 3 months. The criteria of Kane et al. for treatment resistance are as follows: three or more trials with antipsychotic drugs of adequate dose and duration (this is usually 4-6 weeks). The original criteria involved three types of typical neuroleptic drugs. Now, it can include any antipsychotic drug other than clozapine. Olanzapine may have been tried but the dose must not have exceeded 30 mg/day.
- Subjects must have a PANNS-derived BPRS total score > 24 (0-6 scale) or BPRS positive subscale item score > 3 on at least two of the four items.
- Participants will be in generally good and stable physical health.
- Written informed consent will be obtained from all participants after a full explanation of the study and procedures. For those patients with a legal guardian, written informed consent will be obtained from the guardian, with verbal assent by the research subject.
Key exclusion criteria (11 listed)
- Uncontrolled diabetes or hypertension.
- Cardiac conduction abnormality or uncontrolled arrhythmia.
- History of any blood dyscrasia, including leukemia.
- Significant active hepatic or renal disease, including chronic hepatitis.
- Clinically significant neurological disorder, including (but not limited to) Parkinson's disease, multiple sclerosis, seizure disorder, intracranial mass lesion (note that the presence of tardive dyskinesia is not an exclusion for participants).
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 |
|---|---|---|
| olanzapine vs. clozapine | Drug | – |
Primary outcome
There has not been an adequate of test of whether olanzapine is as effective as clozapine in treatment
resistant patients. Several recent studies suggest olanzapine may be effective in some clozapine responders as well as in treatment resistant patients. A head to head comparison is needed to clarify the relative efficacy
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 15 Sep 2005.
- Derived from this study: PubMed 18232726Meltzer HY, Bobo WV, Roy A, Jayathilake K, Chen Y, Ertugrul A, Anil Yagcioglu AE, Small JG. A randomized, double-blind comparison of clozapine and high-dose olanzapine in treatment-resistant patients with schizophrenia. J Clin Psychiatry. 2008 Feb;69(2):274-85. doi: 10.4088/jcp.v69n0214.
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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.
Herbert Y Meltzer, M.D. principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing olanzapine vs. clozapine in people with Schizophrenia and Schizoaffective Disorder, run by Vanderbilt University.
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 6 inclusion and 11 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 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
There has not been an adequate of test of whether olanzapine is as effective as clozapine in treatment. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00179231, which also lists 1 linked publication.
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 15 Sep 2005.