SchizophreniaPhase 4NCT00539071
High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone
A Phase 4 study testing long-acting injectable risperidone, long acting injectable risperidone, Conventional Dose Group and long acting injectable risperidone, High Dose Group in people with Schizophrenia and Schizoaffective Disorder, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to look at two doses of long-acting injectable risperidone (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better at improving symptoms of schizophrenia or… 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?
- long-acting injectable risperidone, long acting injectable risperidone, Conventional Dose Group and long acting injectable risperidone, High Dose Group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 diagnosed with schizophrenia or schizoaffective disorder
- Able to give written informed consent.
- Moderate psychosis persists although compliant with medication
- Patients must have an inadequate response to two antipsychotic medications (can be risperidone, oral or long acting - but not required), at doses that are within the upper end of the standard dosage range
- Patients must have a Clinical Global Impression - Severity (CGI-S) scale score at screening of at least moderate severity and a Personal and Social Performance Scale (PSP) score of 60 or below.
- At the time of screening, eligible patients will be receiving or have received treatment with risperidone oral or Consta, or a combination that does not exceed 50 mg q 2 weeks of Consta or oral risperidone 8 mg/day for at least 6 weeks within seven years of study entry without satisfactory response as documented in the medical record Risperidone
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- Patients who have received Consta injectable medication within the specified dose range for no more than a month prior to the onset of the study will be eligible. Patients receiving mood stabilizers or antidepressants, or both, in addition to risperidone oral or Consta, will be eligible
- Patients may initially be inpatients or outpatients
- Females of childbearing potential will be admitted only if they are on stable birth control medication and understand that they should not get pregnant during the course of the study.
- All patients must have stable housing at the current time or plans for housing following hospital discharge, if an inpatient.
- Patients must be willing to receive injectable medication
Who cannot join
- Patients with a diagnosis other than schizophrenia or schizoaffective disorder.
- Patients previously treated with doses of these agents higher than those allowed for at least six months and who failed to have an adequate response will be excluded
- Patients currently taking clozapine or have failed an adequate trial of clozapine which lasted at least 3 months
- Pregnant females. Females who are currently breastfeeding will be excluded.
- Patients with a diagnosis of substance dependence at screening or up to one year prior to enrollment.
- Patient with worse than mild tardive dyskinesia or history of marked Extrapyramidal Symptoms (EPS) at screening
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- Patients who have had neuroleptic malignant syndrome
- Patients with a history of galactorrhea
- Patients with uncontrolled medical condition(s)
- Patients with a history of non-compliance to oral or injectable medication.
- Patients unwilling to have injectable medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, 37212-8645
About this study
Official title: High Dose Risperidone Consta for Patients With Schizophrenia With Unsatisfactory Response to Standard Dose Risperidone or Long-Acting Injectable
The purpose of this study is to look at two doses of long-acting injectable risperidone (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better at improving symptoms of schizophrenia or schizoaffective disorder.
Read the detailed description
This six month double-blind,randomized trial is designed to compare the efficacy of high dose long acting risperidone ( 75 mg-100 mg q2 weeks or its equivalent) with standard doses of long acting risperidone (≤50 mg/q 2weeks) for Total Psychopathology, positive, negative, and depressive symptoms, and cognition in patients who are considered to be poor responders by themselves, significant others, or clinicians. This will include two types of inadequately responding patients-those who are treatment resistant by research criteria (Kane et al., 1988) and those with inadequate response
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- long-acting injectable risperidone, long acting injectable risperidone, Conventional Dose Group, long acting injectable risperidone, High Dose Group
- Keywords
- schizophrenia, schizoaffective disorder, long acting injectable, treatment resistant
- 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.
long-acting injectable risperidoneDrug
Subjects will be randomized to conventional dose Consta or high dose Consta. All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks. Those who are randomized to high dose Consta will receive a Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose.Oral risperidone will be given up to Week 4 along with the injections for both groups to provide a transition phase.At Week 6, psychopathology will be assessed with a PANSS. If no improvement from baseline is shown, the randomized dose of Consta will be increased to 100 mg q 2 weeks (given as two 50 mg injections ) for those in the high dose Consta group. The dose for those randomized to the conventional dose group will remain the same (50 mg plus placebo).
long acting injectable risperidone, Conventional Dose GroupDrug
Also called Risperidone Consta/Conventional Dose
Study dose remains 50 mg for the length of the study.
long acting injectable risperidone, High Dose GroupDrug
Also called Risperidone Consta/High Dose
Beginning dose 75 mg. Can be increased to 100 mg at Week 6.
| Study group | Role | What they receive |
|---|---|---|
| Conventional dose | Active comparator | All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections.Any oral risperidone the patients receive will be discontinued after Week 4.At Week 6, psychopathology will be assessed with a PANSS. Dose will remain at 50 mg q 2 weeks for those in the conventional Consta dose group. Receives: Drug: long-acting injectable risperidone; Drug: long acting injectable risperidone, Conventional Dose Group |
| High Dose group | Active comparator | Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections. Any oral risperidone the patients receive will be discontinued after Week 4.Psychopathology will be assessed with a PANSS at Week 6. If no improvement since baseline, dose will be increased to two 50 mg injections q 2 weeks for the remainder of the study. Receives: Drug: long-acting injectable risperidone; Drug: long acting injectable risperidone, High Dose Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.
The mean (SEM) of Positive and Negative Syndrome Scale (PANSS) The Positive and Negative Syndrome Scale (PANSS) is a 30-item questionnaire used to assess the severity of symptoms in schizophrenia. It's considered a gold standard for measuring symptom change in antipsychotic trials and other research. The PANSS is divided into three subscales: positive symptoms, negative symptoms, and general psychopathology. Each item is rated on a 7-point scale, ranging from absent to extreme. Therefore, the minimum possible score of 0 and maximum possible score is 210, but those scores may never be seen in a practical setting. If the score reduces over time that indicates improvement of the symptoms.
Measured: six months
Secondary outcomes (2)
Positive and Negative Syndrome Scale (PANSS) Positive Scale
Positive and Negative Syndrome Scale (PANSS) Positive scale:
Consists of sum of 7 items, so the score can range from 0 - 49. Improvement means lower scores over time
Measured: six months
Positive and Negative Syndrome Scale (PANSS) Negative Scale
Positive and Negative Syndrome Scale (PANSS) Negative scale:
Consists of sum of 7 items, so the score can range from 0 - 49. Improvement means lower scores over time
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startMar 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Herbert Meltzer, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539071
- Sponsor's protocol ID
- 070580
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2007
- Last updated
- 1 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Risperidone Consta for Patients With Schizophrenia With Unsatisfactory Response to Standard Dose Risperidone or Long-Acting Injectable
- ClinicalTrials.gov ID
- NCT00539071
- Acronym / sponsor ID
- 070580
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, schizoaffective disorder, long acting injectable, treatment resistant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Mar 2008 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Posted 6 Aug 2025
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 look at two doses of long-acting injectable risperidone (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better at improving symptoms of schizophrenia or schizoaffective disorder.
Detailed description
This six month double-blind,randomized trial is designed to compare the efficacy of high dose long acting risperidone ( 75 mg-100 mg q2 weeks or its equivalent) with standard doses of long acting risperidone (≤50 mg/q 2weeks) for Total Psychopathology, positive, negative, and depressive symptoms, and cognition in patients who are considered to be poor responders by themselves, significant others, or clinicians. This will include two types of inadequately responding patients-those who are treatment resistant by research criteria (Kane et al., 1988) and those with inadequate response
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional dose | Active comparator | Drug: long-acting injectable risperidone, Drug: long acting injectable risperidone, Conventional Dose GroupAll of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections.Any oral risperidone the patients receive will be discontinued after Week 4.At Week 6, psychopathology will be assessed with a PANSS. Dose will remain at 50 mg q 2 weeks for those in the conventional Consta dose group. |
| High Dose group | Active comparator | Drug: long-acting injectable risperidone, Drug: long acting injectable risperidone, High Dose GroupThose who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections. Any oral risperidone the patients receive will be discontinued after Week 4.Psychopathology will be assessed with a PANSS at Week 6. If no improvement since baseline, dose will be increased to two 50 mg injections q 2 weeks for the remainder of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients diagnosed with schizophrenia or schizoaffective disorder
- Able to give written informed consent.
- Moderate psychosis persists although compliant with medication
- Patients must have an inadequate response to two antipsychotic medications (can be risperidone, oral or long acting - but not required), at doses that are within the upper end of the standard dosage range
- Patients must have a Clinical Global Impression - Severity (CGI-S) scale score at screening of at least moderate severity and a Personal and Social Performance Scale (PSP) score of 60 or below.
Key exclusion criteria (11 listed)
- Patients with a diagnosis other than schizophrenia or schizoaffective disorder.
- Patients previously treated with doses of these agents higher than those allowed for at least six months and who failed to have an adequate response will be excluded
- Patients currently taking clozapine or have failed an adequate trial of clozapine which lasted at least 3 months
- Pregnant females. Females who are currently breastfeeding will be excluded.
- Patients with a diagnosis of substance dependence at screening or up to one year prior to enrollment.
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 |
|---|---|---|
| long-acting injectable risperidoneSubjects will be randomized to conventional dose Consta or high dose Consta. All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks. Those who are randomized to high dose Consta will receive a Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose.Oral risperidone will be given up to Week 4 along with the injections for both groups to provide a transition phase.At Week 6, psychopathology will be assessed with a PANSS. If no improvement from baseline is shown, the randomized dose of Consta will be increased to 100 mg q 2 weeks (given as two 50 mg injections ) for those in the high dose Consta group. The dose for those randomized to the conventional dose group will remain the same (50 mg plus placebo). | Drug | Conventional dose, High Dose group |
| long acting injectable risperidone, Conventional Dose GroupAlso: Risperidone Consta/Conventional DoseStudy dose remains 50 mg for the length of the study. | Drug | Conventional dose |
| long acting injectable risperidone, High Dose GroupAlso: Risperidone Consta/High DoseBeginning dose 75 mg. Can be increased to 100 mg at Week 6. | Drug | High Dose group |
Primary outcome
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.
Time frame: six months
The mean (SEM) of Positive and Negative Syndrome Scale (PANSS) The Positive and Negative Syndrome Scale (PANSS) is a 30-item questionnaire used to assess the severity of symptoms in schizophrenia. It's considered a gold standard for measuring symptom change in antipsychotic trials and other research. The PANSS is divided into three subscales: positive symptoms, negative symptoms, and general psychopathology. Each item is rated on a 7-point scale, ranging from absent to extreme. Therefore, the minimum possible score of 0 and maximum possible score is 210, but those scores may never be seen in a practical setting. If the score reduces over time that indicates improvement of the symptoms.
2 secondary outcomes
Positive and Negative Syndrome Scale (PANSS) Positive Scale
Time frame: six months
Positive and Negative Syndrome Scale (PANSS) Negative Scale
Time frame: six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Herbert Meltzer, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing long-acting injectable risperidone, long acting injectable risperidone, Conventional Dose Group and long acting injectable risperidone, High Dose Group in people with Schizophrenia and Schizoaffective Disorder, run by Northwestern University at 1 site in United States.
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 11 inclusion and 11 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks. (time frame: six months). 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 1 Oct 2025; AzTrials last refreshed its copy on 29 Oct 2026.