High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone - Full Text View

Sponsor:	Vanderbilt University
Collaborator:	Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00539071

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: long-acting injectable risperidone Drug: long acting injectable risperidone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	High Dose Risperidone Consta for Patients With Schizophrenia With Unsatisfactory Response to Standard Dose Risperidone or Long-Acting Injectable

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

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 [ Time Frame: six months ] [ Designated as safety issue: No ]

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 [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: long-acting injectable risperidone 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). Drug: long acting injectable risperidone Study dose remains 50 mg for the length of the study. Other Name: Risperidone Consta
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.	Drug: long-acting injectable risperidone 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). Drug: long acting injectable risperidone Beginning dose 75 mg. Can be increased to 100 mg at Week 6. Other Name: Risperidone Consta

Arms

Assigned Interventions

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.

Drug: long-acting injectable risperidone

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).

Drug: long acting injectable risperidone

Study dose remains 50 mg for the length of the study.

Other Name: Risperidone Consta

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.

Drug: long-acting injectable risperidone

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).

Drug: long acting injectable risperidone

Beginning dose 75 mg. Can be increased to 100 mg at Week 6.

Other Name: Risperidone Consta

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539071

Contacts

Contact: Barrett Share, M.A.

615-936-6796

daniel.b.share@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt Psychiatric Hospital	Recruiting
Nashville, Tennessee, United States, 37212-8645
Principal Investigator: Herbert Meltzer, M.D.

Sponsors and Collaborators

Vanderbilt University

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

Principal Investigator:

Herbert Meltzer, M.D.

Vanderbilt University

More Information

No publications provided

Responsible Party:	herbert meltzer, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:	NCT00539071 History of Changes
Other Study ID Numbers:	070580
Study First Received:	October 1, 2007
Last Updated:	November 1, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

schizophrenia
schizoaffective disorder
long acting injectable
treatment resistant

Additional relevant MeSH terms:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on February 09, 2012