SchizophreniaPhase 3NCT00246285
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
A Phase 3 study testing risperidone in people with Schizophrenia and Psychotic Disorders, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of the study is to assess the safety and effectiveness of risperidone (an antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- risperidone
- How many people
- 381 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Dec 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
- Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- expected to benefit from continuous treatment with risperidone, including patients who cannot tolerate their current antipsychotic therapy or are still exhibiting symptoms
- Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score between 40 and 120 at start of study (not required for patients continuing from the 2 previous studies)
Who cannot join
- Meet criteria for other psychiatric disorders or mental retardation (documented IQ <70)
- history of substance dependence (including alcohol, but excluding nicotine and caffeine)
- hypersensitivity or intolerance to risperidone
- extrapyramidal symptoms (EPS) such as tremor that are not adequately controlled with medication
About this study
Official title: The Efficacy And Safety Of Risperidone In The Treatment Of Adolescents With Schizophrenia: A Six-Month Open-Label Study.
The purpose of the study is to assess the safety and effectiveness of risperidone (an antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment.
Read the detailed description
Although the safety and effectiveness of antipsychotic medications is well-established in adults with schizophrenia, these drugs have not been examined rigorously in adolescents with this disorder. Preliminary experience suggests that risperidone may hold promise for the treatment of these younger subjects. This is an open-label, multicenter trial of risperidone, formulated as an oral solution and tablets, in the treatment of adolescents with schizophrenia. It is an open-label, 6-month extension of two previous double-blind studies that assessed the safety and effectiveness of risperidone in the treatment of schizophrenia in an adolescent population. Patients may also enroll directly in this open-label trial. During the first week of the study, patients will receive increasing doses of risperidone to reach an optimal daily dose (2 to 6 mg/day), which will be maintained throughout the 6 months of the study. Assessments of effectiveness include the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), a scale measuring the symptoms of schizophrenia, the Clinical Global Impression-Severity of Illness subscale (CGI-Severity), a scale measuring the severity of illness, the Clinical Global Impression-Improvement subscale (CGI-Improvement), a scale measuring clinical improvement, and the Children's Global Assessment Scale. Safety evaluations include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure, pulse, and temperature), weight, and electrocardiogram (ECG) recordings at specified intervals. The study hypothesis is that risperidone with be effective in the treatment of adolescents with schizophrenia, and well tolerated. Risperidone, oral solution (1 mg/ml) once daily; dose increasing from 0.01 mg/kg body weight (Day 1) to a range from 2 to 6 mg/day for 6 months. Oral tablets (0.5, 1, 2, 3, and 4 mg) once daily; dose increasing from 0.5 mg (Day 1) to a range of 2 to 6 mg/day for 6 months.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- risperidone
- Keywords
- schizophrenia, antipsychotic agents, risperidone, adolescents
- 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.
risperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score from baseline to each visit during treatment; incidence of adverse events throughout study
Secondary outcomes (1)
Clinical Global Impression-Severity of Illness (CGI-Severity) and Clinical Global Impression-Improvement (CGI-Improvement) at each visit; Children's Global Assessment Scale at start and end of study; clinical laboratory tests, vital signs, weight, ECGs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startApr 2001
- Study completionDec 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 381 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
- NCT00246285
- Sponsor's protocol ID
- CR003364
- Status last verified
- Mar 2010
- First submitted
- 28 Oct 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
Publications
Pandina G, Kushner S, Karcher K, Haas M. An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia. Child Adolesc Psychiatry Ment Health. 2012 Jun 7;6(1):23. doi: 10.1186/1753-2000-6-23.
PubMed 22676070
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 The Treatment Of Adolescents With Schizophrenia: A Six-Month Open-Label Study.
- ClinicalTrials.gov ID
- NCT00246285
- Acronym / sponsor ID
- CR003364
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- schizophrenia, antipsychotic agents, risperidone, adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2001
- Study completion
- Dec 2006 (actual)
- First posted
- 31 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.
The purpose of the study is to assess the safety and effectiveness of risperidone (an antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment.
Detailed description
Although the safety and effectiveness of antipsychotic medications is well-established in adults with schizophrenia, these drugs have not been examined rigorously in adolescents with this disorder. Preliminary experience suggests that risperidone may hold promise for the treatment of these younger subjects. This is an open-label, multicenter trial of risperidone, formulated as an oral solution and tablets, in the treatment of adolescents with schizophrenia. It is an open-label, 6-month extension of two previous double-blind studies that assessed the safety and effectiveness of risperidone in the treatment of schizophrenia in an adolescent population. Patients may also enroll directly in this open-label trial. During the first week of the study, patients will receive increasing doses of risperidone to reach an optimal daily dose (2 to 6 mg/day), which will be maintained throughout the 6 months of the study. Assessments of effectiveness include the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), a scale measuring the symptoms of schizophrenia, the Clinical Global Impression-Severity of Illness subscale (CGI-Severity), a scale measuring the severity of illness, the Clinical Global Impression-Improvement subscale (CGI-Improvement), a scale measuring clinical improvement, and the Children's Global Assessment Scale. Safety evaluations include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure, pulse, and temperature), weight, and electrocardiogram (ECG) recordings at specified intervals. The study hypothesis is that risperidone with be effective in the treatment of adolescents with schizophrenia, and well tolerated. Risperidone, oral solution (1 mg/ml) once daily; dose increasing from 0.01 mg/kg body weight (Day 1) to a range from 2 to 6 mg/day for 6 months. Oral tablets (0.5, 1, 2, 3, and 4 mg) once daily; dose increasing from 0.5 mg (Day 1) to a range of 2 to 6 mg/day for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- expected to benefit from continuous treatment with risperidone, including patients who cannot tolerate their current antipsychotic therapy or are still exhibiting symptoms
- Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score between 40 and 120 at start of study (not required for patients continuing from the 2 previous studies)
Key exclusion criteria (4 listed)
- Meet criteria for other psychiatric disorders or mental retardation (documented IQ <70)
- history of substance dependence (including alcohol, but excluding nicotine and caffeine)
- hypersensitivity or intolerance to risperidone
- extrapyramidal symptoms (EPS) such as tremor that are not adequately controlled with medication
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 of Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score from baseline to each visit during treatment; incidence of adverse events throughout study
1 secondary outcome
Clinical Global Impression-Severity of Illness (CGI-Severity) and Clinical Global Impression-Improvement (CGI-Improvement) at each visit; Children's Global Assessment Scale at start and end of study; clinical laboratory tests, vital signs, weight, ECGs.
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 22676070Pandina G, Kushner S, Karcher K, Haas M. An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia. Child Adolesc Psychiatry Ment Health. 2012 Jun 7;6(1):23. doi: 10.1186/1753-2000-6-23.
- A Study of the Effectiveness 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 and Psychotic Disorders, 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 3 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 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 of Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score from baseline to each visit during treatment; incidence of adverse events throughout study. 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 NCT00246285, 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.