A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis
Information source: Janssen-Ortho Inc., Canada
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorders
Intervention: Risperidone long-acting injection (LAI) (Drug); Oral Antipsychotic (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen-Ortho Inc., Canada Official(s) and/or principal investigator(s): Janssen Inc. Clinical Trial, Study Director, Affiliation: Janssen Inc.
Summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of
risperidone long-acting injection (LAI) versus oral antipsychotics in participants with
recent onset psychosis (abnormal thinking and/or hallucinations).
Clinical Details
Official title: An Open-Label Randomized Trial Comparing Risperdal Consta With Oral Antipsychotic Care in the Treatment of Early Psychosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)Time to Relapse Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV
Secondary outcome: Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRVChange From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV Percentage of Participants With Relapse Number of Participants With Cognitive Assessment Using Trail A Number of Participants With Cognitive Assessments Using Trail B Total Words Score Over Time Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV
Detailed description:
This is an open-label (all people know identity of intervention), randomized (the study drug
is assigned by chance), multicenter (conducted in more than 1 center), and exploratory study
in participants with schizophrenia (psychiatric disorder with symptoms of emotional
instability, detachment from reality) or schizoaffective disorder (mixed psychiatric
disorder relating to complex psychotic state that has features of both schizophrenia and
mood disorder). Duration of this study will be 24 months. Study assessment visits will be
conducted at Screening, Baseline, Week 2, every 4 weeks till Week 22, at Week 28, every 12
weeks till Week 88 and at Week 104. All eligible participants will receive either
risperidone long acting injection 25 milligram (mg) intramuscularly (into the muscle) along
with their current oral medication (atypical antipsychotic - risperidone, quetiapine,
olanzapine) or only their current oral medication. Efficacy will be evaluated primarily by
Positive and Negative Syndromes Scale (PANSS), time to relapse and Social and Occupational
Functioning Assessment Scale (SOFAS). Participants's safety will be evaluated throughout the
study mainly by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale
(BARS), and Simpson Angus Scale (SAS).
Eligibility
Minimum age: 18 Years.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- In-patients or out-patients
- Primary Diagnostic and Statistical Manual of Mental Disorders, fourth edition
(DSM-IV) diagnosis of schizophrenia, schizophreniform disorder or schizoaffective
disorder for no longer than 3 years after diagnosis and treatment of a psychotic
illness
- Positive and Negative Syndrome Scale (PANSS) score of 60-120 at Visit 1 and 2
- Currently on monotherapy atypical antipsychotic treatment below local label
guidelines or treatment naive
- Able to complete self-assessments in either English or French
Exclusion Criteria:
- Current primary Axis-1 diagnosis other than schizophrenia, schizophreniform disorder
or schizoaffective disorder, according to DSM-IV
- Current drug or alcohol dependence
- Treatment with a depot antipsychotic within 3 months of study start
- Confirmed or suspected history of lack of tolerability, hypersensitivity or allergy
to risperidone
- Risperidone non-responders (based on evidence of adequate trial of treatment)
Locations and Contacts
Quebec, Canada
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Dartmouth, Nova Scotia, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Markham, Ontario, Canada
Sudbury, Ontario, Canada
Montreal, Quebec, Canada
Verdun, Quebec, Canada
Additional Information
An Open-label Randomized Trial Comparing RISPERDAL*CONSTA* With Oral Antipsychotic Care in the Treatment of Early Psychosis
Starting date: October 2004
Last updated: November 15, 2013
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