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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Schizophreniform Disorder; Psychotic Disorders; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Oral Antipsychotic; Drug: Risperidone long-acting injection (LAI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00246259

CR005959

RISSCH4056

Details and patient eligibility

About

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).

Full 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).

Enrollment: 77 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Risperidone long-acting injection (LAI)

Experimental group

Description:

Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.

Treatment:

Drug: Risperidone long-acting injection (LAI)

Oral Antipsychotic

Active Comparator group

Description:

Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants will be switched to another oral therapy as per Investigator's discretion.

Treatment:

Drug: Oral Antipsychotic