Clinical trial NCT00539071: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
schizoaffective disorder
long acting injectable
treatment resistant
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2007-10-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The primary end point will be change in PANSS Positive Subscale Score in the high dose group using a mixed model ANOVA
timeFrame: six months
Secondary outcomes:
measure: 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
timeFrame: six months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Psychiatric Hospital
state: Tennessee
Study officials:
affiliation: Northwestern University
name: Herbert Meltzer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: