SchizophreniaPhase 4NCT00061802
Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder
A Phase 4 study testing risperidone, quetiapine in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 13 sites in 3 countries.
Trial summary
A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- risperidone, quetiapine
- How many people
- 225 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Jun 2003to Feb 2004
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Current diagnosis of an acute exacerbation of either schizophrenia or schizoaffective disorder
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States7 sites
Study site
Hoffman Est, Illinois
Study site
Jackson, Mississippi
Study site
Lake Charles, Louisiana
Study site
Oklahoma City, Oklahoma
Study site
San Diego, California
Study site
The Bronx, New York
Study site
Visakhapatnam, Missouri
India4 sites
Study site
Chhatrapati Sambhajinagar
Study site
New Delhi
Study site
Orange
Study site
San Diego
About this study
Official title: A Randomized, Double Blind Study to Evaluate the Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder
A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder
Read the detailed description
This study was intended to compare the efficacy and safety of risperidone, quetiapine, and placebo in the treatment of patients with acute exacerbations of schizophrenia or schizoaffective disorder. The primary tested hypothesis was a comparison of the efficacy of risperidone and quetiapine (active combined group) to placebo. Other a priori hypotheses tested included comparison of the onset of antipsychotic effect of risperidone to quetiapine and placebo, and to evaluate the efficacy, safety, and cost of risperidone compared with quetiapine in the treatment of subjects with an acute exacerbation of schizophrenia or schizoaffective disorder.
During the first phase of the study (15 days), patients randomized to risperidone were titrated from 1 mg to 4 mg or from 1 mg to 6 mg per day, depending on body weight. Patients randomized to quetiapine were titrated from 50 mg to 400 mg or from 50 mg to 600 mg per day, depending on body weight. Based on investigators determination of patient clinical response, patients in the quetiapine group could be titrated to a maximum of 600 mg or 800 mg per day depending on body weight.
During the second phase of the study (days 15 - 42), patients continue to take the dose of study medication taken in the first phase, but additional psychotropic medication could be added as clinically necessary to control symptoms in patients who remained sufficiently symptomatic (defined as a certain minimum value on a clinical global severity scale.)
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- risperidone, quetiapine
- 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.
risperidone, quetiapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of combined risperidone and quetiapine groups versus placebo based on change in psychotic symptoms scale from baseline to two weeks.
Secondary outcomes (1)
Comparison of response rates based on proportion of patients in each study group that reach a predetermined percent decrease in psychotic symptom score at two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2003 (estimated)
- Study startJun 2003
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061802
- Sponsor's protocol ID
- CR002890
- Status last verified
- Feb 2012
- First submitted
- 4 Jun 2003
- Last updated
- 7 Feb 2012
- Results posted
- No
Publications
Gharabawi GM, Greenspan A, Rupnow MF, Kosik-Gonzalez C, Bossie CA, Zhu Y, Kalali AH, Awad AG. Reduction in psychotic symptoms as a predictor of patient satisfaction with antipsychotic medication in schizophrenia: data from a randomized double-blind trial. BMC Psychiatry. 2006 Oct 20;6:45. doi: 10.1186/1471-244X-6-45.
PubMed 17054789
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Study to Evaluate the Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00061802
- Acronym / sponsor ID
- CR002890
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Study start
- Jun 2003
- Study completion
- Feb 2004 (actual)
- First posted
- 5 Jun 2003 (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.
A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder
Detailed description
This study was intended to compare the efficacy and safety of risperidone, quetiapine, and placebo in the treatment of patients with acute exacerbations of schizophrenia or schizoaffective disorder. The primary tested hypothesis was a comparison of the efficacy of risperidone and quetiapine (active combined group) to placebo. Other a priori hypotheses tested included comparison of the onset of antipsychotic effect of risperidone to quetiapine and placebo, and to evaluate the efficacy, safety, and cost of risperidone compared with quetiapine in the treatment of subjects with an acute exacerbation of schizophrenia or schizoaffective disorder.
During the first phase of the study (15 days), patients randomized to risperidone were titrated from 1 mg to 4 mg or from 1 mg to 6 mg per day, depending on body weight. Patients randomized to quetiapine were titrated from 50 mg to 400 mg or from 50 mg to 600 mg per day, depending on body weight. Based on investigators determination of patient clinical response, patients in the quetiapine group could be titrated to a maximum of 600 mg or 800 mg per day depending on body weight.
During the second phase of the study (days 15 - 42), patients continue to take the dose of study medication taken in the first phase, but additional psychotropic medication could be added as clinically necessary to control symptoms in patients who remained sufficiently symptomatic (defined as a certain minimum value on a clinical global severity scale.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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, quetiapine | Drug | – |
Primary outcome
Efficacy of combined risperidone and quetiapine groups versus placebo based on change in psychotic symptoms scale from baseline to two weeks.
1 secondary outcome
Comparison of response rates based on proportion of patients in each study group that reach a predetermined percent decrease in psychotic symptom score at two 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 7 Feb 2012.
- Results publication: PubMed 17054789Gharabawi GM, Greenspan A, Rupnow MF, Kosik-Gonzalez C, Bossie CA, Zhu Y, Kalali AH, Awad AG. Reduction in psychotic symptoms as a predictor of patient satisfaction with antipsychotic medication in schizophrenia: data from a randomized double-blind trial. BMC Psychiatry. 2006 Oct 20;6:45. doi: 10.1186/1471-244X-6-45.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing risperidone, quetiapine in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, India, Romania. 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?
Efficacy of combined risperidone and quetiapine groups versus placebo based on change in psychotic symptoms scale from baseline to two weeks.. 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 NCT00061802, 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 7 Feb 2012.