SchizophreniaPhase 4NCT00237861
Effectiveness of Atypical Versus Conventional Antipsychotics in Treating Schizophrenia
A Phase 4 study testing risperidone, olanzapine and quetiapine in people with Schizophrenia, run by Yale University.
Trial summary
This study will compare the effectiveness of newer atypical antipsychotics versus older conventional antipsychotics in treating schizophrenia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia
- What is being tested?
- risperidone, olanzapine and quetiapine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hospitalized for schizophrenia
Who cannot join
- none
About this study
Official title: Effectiveness of Atypical Vs Conventional Antipsychotics
This study will compare the effectiveness of newer atypical antipsychotics versus older conventional antipsychotics in treating schizophrenia.
Read the detailed description
At seven participating hospitals, acutely exacerbated patients with schizophrenia were randomly assigned to treatment with antipsychotic from the atypical class vs antipsychotic from the conventional class. Medication choice within class, dose, concomitant medications, and other prescribing decisions were left to the community prescriber. Patients were followed for one year after discharge.
- Conditions
- Schizophrenia
- Being tested
- risperidone, olanzapine, quetiapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
olanzapineDrug
quetiapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS
Retention.
Secondary outcomes (1)
EPS, TD.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Primary completionDec 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.
- More trials run by Yale UniversityThe 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
- Single blind
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Scott W Woods, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237861
- Sponsor's protocol ID
- MH57292
- Other IDs
- R01MH057292
- Status last verified
- Jun 2014
- First submitted
- 7 Oct 2005
- Last updated
- 6 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Atypical Vs Conventional Antipsychotics
- ClinicalTrials.gov ID
- NCT00237861
- Acronym / sponsor ID
- MH57292
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Primary completion
- Dec 2002 (actual)
- First posted
- 12 Oct 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 compare the effectiveness of newer atypical antipsychotics versus older conventional antipsychotics in treating schizophrenia.
Detailed description
At seven participating hospitals, acutely exacerbated patients with schizophrenia were randomly assigned to treatment with antipsychotic from the atypical class vs antipsychotic from the conventional class. Medication choice within class, dose, concomitant medications, and other prescribing decisions were left to the community prescriber. Patients were followed for one year after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- hospitalized for schizophrenia
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| risperidone | Drug | – |
| olanzapine | Drug | – |
| quetiapine | Drug | – |
Primary outcome
PANSS
Retention.
1 secondary outcome
EPS, TD.
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 6 Jun 2014.
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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.
Scott W Woods, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing risperidone, olanzapine and quetiapine in people with Schizophrenia, run by Yale 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 1 inclusion and 1 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 6 Jun 2014. 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.
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. 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?
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 6 Jun 2014.