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

NCT00539071 | Completed Phase 4 Results

• 1 other identifier: 070580
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; schizoaffective disorder; long acting injectable; treatment resistant

Outcome Measures

Primary Outcomes (1)

• 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.

  six months

Secondary Outcomes (2)

• Positive and Negative Syndrome Scale (PANSS) Positive Scale

  six months

• Positive and Negative Syndrome Scale (PANSS) Negative Scale

  six months

Study Arms (2)

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.

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.

Drug: long-acting injectable risperidone; Drug: long acting injectable risperidone, High Dose Group

Interventions

long-acting injectable risperidone DRUG

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).

Conventional dose; High Dose group

long acting injectable risperidone, Conventional Dose Group DRUG

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

Also known as: Risperidone Consta/Conventional Dose

Conventional dose

long acting injectable risperidone, High Dose Group DRUG

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

Also known as: Risperidone Consta/High Dose

High Dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northwestern University: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Vanderbilt Psychiatric Hospital

Nashville, Tennessee, 37212-8645, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Results Point of Contact

• Title: Dr. Herbert Meltzer
• Organization: Northwestern University

h-meltzer@northwestern.edu

(312) 503-0309

Study Officials

• Herbert Meltzer, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 3, 2007
• Study Start: March 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 1, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-09

Locations

US (1)