Schizoaffective DisorderPhase 4NCT00378183
A Study Comparing Three Strategies to Switch Patients With Schizophrenia or Schizoaffective Disorder to Risperidone After Unsuccessful Treatment With Olanzapine.
A Phase 4 study testing risperidone in people with Schizoaffective Disorder and Schizophrenia, run by Janssen, LP.
Trial summary
The purpose of this study is to compare three strategies for switching patients with schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizoaffective Disorder, Schizophrenia
- What is being tested?
- risperidone
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to May 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of schizophrenia or schizoaffective disorder
- Taking a stable dose of olanzapine for at least 30 days
- Have not experienced an acute exacerbation of their psychotic symptoms in the preceding 3 months
- Either had only a marginal clinical response to olanzapine, or had unacceptable side effects related to weight gain including obesity, diabetes or abnormal glucose metabolism
Who cannot join
- Patients with a history of treatment failure with, or significant adverse events attributable to, risperidone, or known sensitivity to risperidone
- A history of antipsychotic therapy other than olanzapine in the 30 days preceding randomization
- Presence of serious or unstable illnesses: liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances
- Diagnosis of substance dependence
- Pregnant or nursing female, or those lacking adequate contraception
About this study
Official title: A Randomized Open-Label, Rater Blinded Assessment of Optimal Treatment Change Strategy to Risperidone for Patients Intolerant of Olanzapine
The purpose of this study is to compare three strategies for switching patients with schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. In the second phase of this study, investigators will assess the effectiveness of behavioral therapy in reducing body weight in risperdone-treated patients who are overweight or have problems with diabetes or blood sugar.
Read the detailed description
Data regarding the safety and effectiveness of different strategies for switching subjects with schizophrenia from one antipsychotic medication to another are very rare. Studies that have examined various switching designs, especially with regard to the newer atypical antipsychotic agents, suggest that either abrupt or gradual discontinuation does not inevitably lead to worsening of symptoms. This study is randomized (patients are assigned different treatments based on chance), open-label, with a parallel group design to assess the safety and effectiveness of each of three strategies of discontinuing olanzapine and starting risperidone. The first strategy is the discontinuation of olanzapine on the day risperidone is started. The second strategy involves a reduction in the dose of olanzapine to one half of the study entry dose on the day risperidone is started. The reduced dose of olanzapine is to be given for one week and then discontinued. In the third strategy, the dose of olanzapine remains unchanged for the first week, then is reduced by one half of the study entry dose, and at the end of the second week is discontinued. In all three strategies, patients take the same dose of risperidone: 1 mg by mouth twice a day for 3 days, then 2 mg twice a day for the next 4 days. Further increase or decrease of risperidone dose and/or changing to a single daily dose can be carried out at the end of the first week. Additionally, after 6 weeks of risperidone therapy, patients who are overweight or have problems with diabetes or blood sugar may enter a second phase of the study that examines weight loss. In this phase, patients are randomized to receive routine clinical care or training on weight management behavioral techniques while continuing to take risperidone for an additional 14 weeks. At the end of 14 weeks, total weight loss, changes in lipids, cholesterol and other laboratory measures will be compared between the two groups. The study hypothesis is that symptom improvement or worsening at week 14, as measured by total score on the Positive and Negative Syndrome Scale (PANSS), should not differ depending on the method of switching from olanzapine to risperidone. Safety evaluations incude collection of adverse events, clinical laboratory tests and assessment of vital signs.
The patients will receive oral tablets of risperidone 1 to 2 milligram[mg] twice a day (higher or lower dose and/or changing to single daily dose allowed at end of the first week) for the duration of 6 weeks in phase 1, and then for 14 more weeks in phase 2 of the study. Olanzapine: none; or half of the study entry dose for 1 week; or study entry dose for 1 week, then half of the study entry dose for an additional week.
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Being tested
- risperidone
- Keywords
- weight loss, behavioral therapy, risperidone, switching antipsychotics, schizoaffective disorder, Risperdal, schizophrenia, olanzapine, Zyprexa
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Weight Loss
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.
The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.
Secondary outcomes (1)
The change from baseline in Client Satisfaction Questionnaire (CSQ-8) score at week 14 of Phase 2 and the change from baseline in Global Assessment of Functioning (GAF) score at week 14 of Phase 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startFeb 2001
- Study completionMay 2002
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 Schizoaffective DisorderStudies 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen, LP Clinical Trial, Study director, Janssen, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378183
- Sponsor's protocol ID
- CR012520
- Status last verified
- Apr 2010
- First submitted
- 15 Sep 2006
- Last updated
- 27 Apr 2010
- Results posted
- No
Publications
Ganguli R, Brar JS, Mahmoud R, Berry SA, Pandina GJ. Assessment of strategies for switching patients from olanzapine to risperidone: a randomized, open-label, rater-blinded study. BMC Med. 2008 Jun 30;6:17. doi: 10.1186/1741-7015-6-17.
PubMed 18590519
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-Label, Rater Blinded Assessment of Optimal Treatment Change Strategy to Risperidone for Patients Intolerant of Olanzapine
- ClinicalTrials.gov ID
- NCT00378183
- Acronym / sponsor ID
- CR012520
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Keywords
- weight loss, behavioral therapy, risperidone, switching antipsychotics, schizoaffective disorder, Risperdal, schizophrenia, olanzapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Janssen, LPIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Study completion
- May 2002 (actual)
- First posted
- 19 Sep 2006 (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 this study is to compare three strategies for switching patients with schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. In the second phase of this study, investigators will assess the effectiveness of behavioral therapy in reducing body weight in risperdone-treated patients who are overweight or have problems with diabetes or blood sugar.
Detailed description
Data regarding the safety and effectiveness of different strategies for switching subjects with schizophrenia from one antipsychotic medication to another are very rare. Studies that have examined various switching designs, especially with regard to the newer atypical antipsychotic agents, suggest that either abrupt or gradual discontinuation does not inevitably lead to worsening of symptoms. This study is randomized (patients are assigned different treatments based on chance), open-label, with a parallel group design to assess the safety and effectiveness of each of three strategies of discontinuing olanzapine and starting risperidone. The first strategy is the discontinuation of olanzapine on the day risperidone is started. The second strategy involves a reduction in the dose of olanzapine to one half of the study entry dose on the day risperidone is started. The reduced dose of olanzapine is to be given for one week and then discontinued. In the third strategy, the dose of olanzapine remains unchanged for the first week, then is reduced by one half of the study entry dose, and at the end of the second week is discontinued. In all three strategies, patients take the same dose of risperidone: 1 mg by mouth twice a day for 3 days, then 2 mg twice a day for the next 4 days. Further increase or decrease of risperidone dose and/or changing to a single daily dose can be carried out at the end of the first week. Additionally, after 6 weeks of risperidone therapy, patients who are overweight or have problems with diabetes or blood sugar may enter a second phase of the study that examines weight loss. In this phase, patients are randomized to receive routine clinical care or training on weight management behavioral techniques while continuing to take risperidone for an additional 14 weeks. At the end of 14 weeks, total weight loss, changes in lipids, cholesterol and other laboratory measures will be compared between the two groups. The study hypothesis is that symptom improvement or worsening at week 14, as measured by total score on the Positive and Negative Syndrome Scale (PANSS), should not differ depending on the method of switching from olanzapine to risperidone. Safety evaluations incude collection of adverse events, clinical laboratory tests and assessment of vital signs.
The patients will receive oral tablets of risperidone 1 to 2 milligram[mg] twice a day (higher or lower dose and/or changing to single daily dose allowed at end of the first week) for the duration of 6 weeks in phase 1, and then for 14 more weeks in phase 2 of the study. Olanzapine: none; or half of the study entry dose for 1 week; or study entry dose for 1 week, then half of the study entry dose for an additional week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of schizophrenia or schizoaffective disorder
- Taking a stable dose of olanzapine for at least 30 days
- Have not experienced an acute exacerbation of their psychotic symptoms in the preceding 3 months
- Either had only a marginal clinical response to olanzapine, or had unacceptable side effects related to weight gain including obesity, diabetes or abnormal glucose metabolism
Key exclusion criteria (5 listed)
- Patients with a history of treatment failure with, or significant adverse events attributable to, risperidone, or known sensitivity to risperidone
- A history of antipsychotic therapy other than olanzapine in the 30 days preceding randomization
- Presence of serious or unstable illnesses: liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances
- Diagnosis of substance dependence
- Pregnant or nursing female, or those lacking adequate contraception
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
The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.
1 secondary outcome
The change from baseline in Client Satisfaction Questionnaire (CSQ-8) score at week 14 of Phase 2 and the change from baseline in Global Assessment of Functioning (GAF) score at week 14 of Phase 2.
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 27 Apr 2010.
- Derived from this study: PubMed 18590519Ganguli R, Brar JS, Mahmoud R, Berry SA, Pandina GJ. Assessment of strategies for switching patients from olanzapine to risperidone: a randomized, open-label, rater-blinded study. BMC Med. 2008 Jun 30;6:17. doi: 10.1186/1741-7015-6-17.
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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.
Janssen, LP Clinical Trial study director
Janssen, LP
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing risperidone in people with Schizoaffective Disorder and Schizophrenia, run by Janssen, LP.
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 4 inclusion and 5 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 27 Apr 2010. 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?
The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.. 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 NCT00378183, 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 27 Apr 2010.