- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00539071
High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone
July 17, 2019 updated by: Herbert Meltzer, Northwestern University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37212-8645
- Vanderbilt Psychiatric Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 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
- 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 child bearing 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
Exclusion Criteria:
- 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 EPS at screening
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional dose
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.
|
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).
Study dose remains 50 mg for the length of the study.
Other Names:
Beginning dose 75 mg.
Can be increased to 100 mg at Week 6.
Other Names:
|
Active Comparator: High Dose group
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.
|
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).
Study dose remains 50 mg for the length of the study.
Other Names:
Beginning dose 75 mg.
Can be increased to 100 mg at Week 6.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary end point will be change in PANSS Positive Subscale Score in the high dose group using a mixed model ANOVA
Time Frame: six months
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in PANSS; time to discontinuation for lack of efficacy and tolerability; change in cognitive domain scores; comparative incidence and time course of EPS, hyperprolactinemia, plasma lipids, weight gain, and other side effects between treatments
Time Frame: six months
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Herbert Meltzer, M.D., Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2008
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
October 1, 2007
First Submitted That Met QC Criteria
October 2, 2007
First Posted (Estimate)
October 3, 2007
Study Record Updates
Last Update Posted (Actual)
July 19, 2019
Last Update Submitted That Met QC Criteria
July 17, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- 070580
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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