A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis

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.

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).

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 LRV

Change 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).

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)

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

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