SchizophreniaPhase 4COESNCT00169065
Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia
A Phase 4 study testing Clozapine and Olanzapine in people with Schizophrenia, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
Trial summary
This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Clozapine and Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Jun 2002
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-60 years;
- Diagnosis of treatment refractory schizophrenia or schizoaffective disorder;
- BPRS score > 21 (0-6) scale;
- Either two 6-8 week trials of typical neuroleptics given at a dosage of 600 mg/day of CPZ or its equivalent or one 6-8 week trial of an atypical antipsychotic at a reasonable dose (i.e. risperidone 4-6 mg/day);
- The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
- Clinically appropriate for clozapine or olanzapine
Who cannot join
- Current substance abuse;
- Suicide or homicide risk;
- Pregnancy or lactation;
- History of seizures or blood dyscrasias
Trial locations and contacts
1 site in 1 country.
United States1 site
Commonwealth Research Center
Jamaica Plain, Massachusetts, 02130
About this study
Official title: Clozapine vs. Olanzapine: An Effectiveness Study
This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.
Read the detailed description
This is a two-year open-label, randomized trial of the comparative effectiveness of clozapine versus olanzapine in patients with treatment refractory schizophrenia. The objective is to determine whether in a naturalistic setting olanzapine is a logical treatment choice (before using the more toxic clozapine) for some treatment refractory patients.
- Conditions
- Schizophrenia
- Being tested
- Clozapine, Olanzapine
- Keywords
- Clozapine, olanzapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClozapineDrug
OlanzapineDrug
| Study group | Role | What they receive |
|---|---|---|
| Clozapine | Active comparator | Clozapine or olanzapine in treatment resistant schizophrenia Receives: Drug: Clozapine |
| olanzapine | Active comparator | clozapine or olanzapine in treatment resistant schizophrenia Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life.
Secondary outcomes (1)
Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.
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 startAug 1998
- Primary completionJun 2002
- Study completionJun 2002
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Commonwealth Research Center, Massachusetts, Eli Lilly and Company
- Responsible party
- Principal investigator, AlanGreen, National Institute of Mental Health (NIMH)
- Investigators
- Alan I Green, MD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169065
- Sponsor's protocol ID
- R01MH049891
- Other IDs
- R01MH049891
- Acronym
- COES
- Status last verified
- Apr 2015
- First submitted
- 10 Sep 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clozapine vs. Olanzapine: An Effectiveness Study
- ClinicalTrials.gov ID
- NCT00169065
- Acronym / sponsor ID
- COES / R01MH049891
- Conditions
- Schizophrenia
- Keywords
- Clozapine, olanzapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Commonwealth Research Center, Massachusetts, Eli Lilly and Company
- Study start
- Aug 1998
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- 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.
This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.
Detailed description
This is a two-year open-label, randomized trial of the comparative effectiveness of clozapine versus olanzapine in patients with treatment refractory schizophrenia. The objective is to determine whether in a naturalistic setting olanzapine is a logical treatment choice (before using the more toxic clozapine) for some treatment refractory patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clozapine | Active comparator | Drug: ClozapineClozapine or olanzapine in treatment resistant schizophrenia |
| olanzapine | Active comparator | Drug: Olanzapineclozapine or olanzapine in treatment resistant schizophrenia |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20-60 years;
- Diagnosis of treatment refractory schizophrenia or schizoaffective disorder;
- BPRS score > 21 (0-6) scale;
- Either two 6-8 week trials of typical neuroleptics given at a dosage of 600 mg/day of CPZ or its equivalent or one 6-8 week trial of an atypical antipsychotic at a reasonable dose (i.e. risperidone 4-6 mg/day);
- The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
Key exclusion criteria (4 listed)
- Current substance abuse;
- Suicide or homicide risk;
- Pregnancy or lactation;
- History of seizures or blood dyscrasias
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 |
|---|---|---|
| Clozapine | Drug | Clozapine |
| Olanzapine | Drug | olanzapine |
Primary outcome
Changes in quality of life.
1 secondary outcome
Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.
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 7 Apr 2015.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Alan I Green, MD principal investigator
Harvard Medical School (HMS and HSDM)
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 Clozapine and Olanzapine in people with Schizophrenia, run by Harvard Medical School (HMS and HSDM) at 1 site 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 6 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 7 Apr 2015. 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 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?
Changes in quality of life.. 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 7 Apr 2015.