SchizophreniaPhase 3NCT00034749
The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
A Phase 3 study testing Risperidone in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone
- How many people
- 279 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Mar 2006
- Phase
- Phase 3
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects will be eligible for study enrollment if they: are adolescents between the ages of 13 and 17 years
- have a confirmed diagnosis of schizophrenia and are suffering from an acute episode
- provide their assent and parental informed consent to participate
- are otherwise relatively healthy on the basis of a medical and physical examination
- and are able to be in-patients for approximately 2 weeks.
Who cannot join
- Subjects will be excluded from the study if they: meet the criteria for psychiatric disorders other than schizophrenia
- have moderate or severe mental retardation
- fail to respond to treatment with at least two typical or atypical antipsychotics
- have a history of substance dependence within the 3 months before screening
- are considered at risk for suicidal or violent behavior
- have a seizure disorder
- have a history of neuroleptic malignant syndrome, similar encephalopathic syndrome, or tardive dyskinesia
- or receive prohibited medication within a specified period before screening.
About this study
Official title: The Efficacy and Safety of Risperidone in Adolescents With Schizophrenia: a Comparison of Two Dose Ranges of Risperidone
A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.
Read the detailed description
This is a clinical study of an investigational drug called risperidone in the treatment of schizophrenia in adolescents. Initially children (age 2 to 12 yrs) and schizophreniform subjects were also allowed but excluded following protocol amendment.
The study will include approximately 260 patients aged 13 to 17 years with a diagnosis of schizophrenia. Subjects will be randomly assigned to one of two groups on enrollment and will be given risperidone as an oral solution each day for 8 weeks at doses within one of two dose different ranges, according to the assigned study group.
Initially the two dose range were 0.15-0.4 mg/day and 1.5-4mg/day but were changed in protocol amendment to evaluate the maximum tolerated dose with a minimum of 3.5mg/day and maximum of 6mg/day (resp. 0.35 and 0.6mg/day in low dose treatment arm) Risperidone lower dose (0.35-0.6 mg/day [subjects >=50kg] or 0.007-0.012 mg/kg/day [subjects <50 kg]) as 0.1 mg/mL oral solution or risperidone higher dose (3.5-6 mg/day [subjects >=50 kg] or 0.07-0.12 mg/kg/day [subjects <50 kg]) as 1 mg/mL oral solution for 8 weeks. Daily dose can be given all at once or through 2 administrations (in morning and evening); the dose is increased based on efficacy and tolerability.
- Conditions
- Schizophrenia
- Being tested
- Risperidone
- Keywords
- Adolescents, Schizophrenia, risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
Secondary outcomes (1)
Change from baseline in PANSS subscale scores and Clinical Global Impression (CGI-S and CGI-I) scores, number of subjects achieving a clinical response (at least 20% improvement in total PANSS), safety, tolerability and pharmacokinetics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startApr 2001
- Study completionMar 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034749
- Sponsor's protocol ID
- CR003361
- Status last verified
- Mar 2010
- First submitted
- 2 May 2002
- Last updated
- 8 Jun 2011
- Results posted
- No
Publications
Haas M, Eerdekens M, Kushner S, Singer J, Augustyns I, Quiroz J, Pandina G, Kusumakar V. Efficacy, safety and tolerability of two dosing regimens in adolescent schizophrenia: double-blind study. Br J Psychiatry. 2009 Feb;194(2):158-64. doi: 10.1192/bjp.bp.107.046177.
PubMed 19182179
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Risperidone in Adolescents With Schizophrenia: a Comparison of Two Dose Ranges of Risperidone
- ClinicalTrials.gov ID
- NCT00034749
- Acronym / sponsor ID
- CR003361
- Conditions
- Schizophrenia
- Keywords
- Adolescents, Schizophrenia, risperidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2001
- Study completion
- Mar 2006 (actual)
- First posted
- 3 May 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.
A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.
Detailed description
This is a clinical study of an investigational drug called risperidone in the treatment of schizophrenia in adolescents. Initially children (age 2 to 12 yrs) and schizophreniform subjects were also allowed but excluded following protocol amendment.
The study will include approximately 260 patients aged 13 to 17 years with a diagnosis of schizophrenia. Subjects will be randomly assigned to one of two groups on enrollment and will be given risperidone as an oral solution each day for 8 weeks at doses within one of two dose different ranges, according to the assigned study group.
Initially the two dose range were 0.15-0.4 mg/day and 1.5-4mg/day but were changed in protocol amendment to evaluate the maximum tolerated dose with a minimum of 3.5mg/day and maximum of 6mg/day (resp. 0.35 and 0.6mg/day in low dose treatment arm) Risperidone lower dose (0.35-0.6 mg/day [subjects >=50kg] or 0.007-0.012 mg/kg/day [subjects <50 kg]) as 0.1 mg/mL oral solution or risperidone higher dose (3.5-6 mg/day [subjects >=50 kg] or 0.07-0.12 mg/kg/day [subjects <50 kg]) as 1 mg/mL oral solution for 8 weeks. Daily dose can be given all at once or through 2 administrations (in morning and evening); the dose is increased based on efficacy and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects will be eligible for study enrollment if they: are adolescents between the ages of 13 and 17 years
- have a confirmed diagnosis of schizophrenia and are suffering from an acute episode
- provide their assent and parental informed consent to participate
- are otherwise relatively healthy on the basis of a medical and physical examination
- and are able to be in-patients for approximately 2 weeks.
Key exclusion criteria (8 listed)
- Subjects will be excluded from the study if they: meet the criteria for psychiatric disorders other than schizophrenia
- have moderate or severe mental retardation
- fail to respond to treatment with at least two typical or atypical antipsychotics
- have a history of substance dependence within the 3 months before screening
- are considered at risk for suicidal or violent behavior
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 | – |
Primary outcome
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
1 secondary outcome
Change from baseline in PANSS subscale scores and Clinical Global Impression (CGI-S and CGI-I) scores, number of subjects achieving a clinical response (at least 20% improvement in total PANSS), safety, tolerability and pharmacokinetics.
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 8 Jun 2011.
- Derived from this study: PubMed 19182179Haas M, Eerdekens M, Kushner S, Singer J, Augustyns I, Quiroz J, Pandina G, Kusumakar V. Efficacy, safety and tolerability of two dosing regimens in adolescent schizophrenia: double-blind study. Br J Psychiatry. 2009 Feb;194(2):158-64. doi: 10.1192/bjp.bp.107.046177.
- The Efficacy and Safety of Risperidone in the Treatment of Adolescents With SchizophreniaLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 inclusion and 8 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 8 Jun 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint. 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 NCT00034749, 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 8 Jun 2011.