Clinical trial NCT00246259: A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis
Official title: An Open-Label Randomized Trial Comparing Risperdal Consta With Oral Antipsychotic Care in the Treatment of Early Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Psychotic Disorders
Keywords: Schizophrenia
Schizoaffective disorder
Schizophreniform disorder
Risperidone
Risperdal Consta
Lead sponsor: Janssen-Ortho Inc., Canada
Sponsor class: INDUSTRY
First posted: 2005-10-30
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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)

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)
timeFrame: Baseline, Week 104 or LRV
measure: Time to Relapse
timeFrame: Week 10 (post-stability) up to Week 104 or LRV
measure: Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV
timeFrame: Baseline, Week 104 or LRV
Secondary outcomes:
measure: Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV
timeFrame: Baseline, Week 104 or LRV
measure: Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV
timeFrame: Baseline, Week 104 or LRV
measure: Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV
timeFrame: Baseline, Week 104 or LRV
measure: Percentage of Participants With Relapse
timeFrame: Week 10 (post-stability) up to Week 104 or LRV
measure: Number of Participants With Cognitive Assessment Using Trail A
timeFrame: Week -2, 104 or LRV
measure: Number of Participants With Cognitive Assessments Using Trail B
timeFrame: Week -2, 104 or LRV
measure: Total Words Score Over Time
timeFrame: Baseline, Week 104 or LRV
measure: Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV
timeFrame: Up to Week 104 or LRV
measure: Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV
timeFrame: Up to Week 104 or LRV
Other outcomes:
measure: Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
timeFrame: Baseline, Week 104 or LRV
measure: Simpson Angus Scale (SAS)
timeFrame: Baseline, Week 104 or LRV
measure: Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Baseline, Week 104 or LRV
Locations:
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Dartmouth
country: Canada
state: Nova Scotia
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Verdun
country: Canada
state: Quebec
city: Quebec
country: Canada
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References: