search
Back to results

High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
long-acting injectable risperidone
long acting injectable risperidone
long acting injectable risperidone
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorder, long acting injectable, treatment resistant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional dose

High Dose group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The primary end point will be change in PANSS Positive Subscale Score in the high dose group using a mixed model ANOVA

Secondary Outcome Measures

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

Full Information

First Posted
October 1, 2007
Last Updated
July 17, 2019
Sponsor
Northwestern University
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT00539071
Brief Title
High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone
Official Title
High Dose Risperidone Consta for Patients With Schizophrenia With Unsatisfactory Response to Standard Dose Risperidone or Long-Acting Injectable
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2008 (Actual)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
schizophrenia, schizoaffective disorder, long acting injectable, treatment resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Dose group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
long-acting injectable risperidone
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
long acting injectable risperidone
Other Intervention Name(s)
Risperidone Consta
Intervention Description
Study dose remains 50 mg for the length of the study.
Intervention Type
Drug
Intervention Name(s)
long acting injectable risperidone
Other Intervention Name(s)
Risperidone Consta
Intervention Description
Beginning dose 75 mg. Can be increased to 100 mg at Week 6.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Meltzer, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Psychiatric Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-8645
Country
United States

12. IPD Sharing Statement

Learn more about this trial

High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone

We'll reach out to this number within 24 hrs