An Open-Label Randomized Trial Comparing Long-Acting Injectable Risperidone With Oral Antipsychotic Medication in the Treatment of Early Psychosis

Condition(s) targeted: Schizophrenia; Psychotic Disorders

Intervention: risperidone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Janssen-Ortho Inc., Canada

Official(s) and/or principal investigator(s):
Janssen-Ortho Inc. Clinical Trial, Study Director, Affiliation: Janssen-Ortho Inc., Canada

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of administering long-acting injectable risperidone versus oral antipsychotic medication in patients with recently diagnosed psychosis.

Official title: An Open-Label Randomized Trial Comparing RISPERDAL® CONSTA™ (Risperidone) With Oral Antipsychotic Care in the Treatment of Early Psychosis

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Primary evaluations will be measured by total symptoms as assessed by the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) scores; time to relapse; social, occupational and functional outcomes

Secondary outcome: Secondary evaluations will include co-morbid depressive symptoms, as measured by symptoms of mania; symptoms of anxiety as measured by the CDSS, YMRS, and HAM-A scores; and relapse rates. Safety is evaluated throughout the study.

Detailed description: This is an open-label, randomized, 24-month, 2-arm multicentre study to evaluate the effectiveness, safety and tolerability of long-acting injectable risperidone in patients with recent onset (< 3 years) schizophrenia, schizophreniform disorder, or schizoaffective disorder. A total of 84 patients will be randomized to receive either long-acting risperidone injections every 2 weeks or continue their current oral antipsychotic (risperidone, quetiapine, or olanzapine) treatment for a period of 24 months, to assess symptoms/outcomes and safety. Patients randomized to the risperidone long-acting injectable formulation will be administered 25 mg of risperidone at Day 1 and subsequent injections will be administered every 2 weeks. The risperidone long-acting injectable group will continue their oral atypical antipsychotic (AAP) dose or receive oral risperidone (treatment-naïve patients) supplementation for 3 weeks. The dose of long-acting risperidone injection may be increased in 12. 5 mg increments, to a maximum dose of 50 mg. Oral supplementation with risperidone is given with each dose increase. In the oral atypical antipsychotic only group, the dose of the oral AAP can also be increased as required. The efficacy outcomes include the impact of therapy on positive, negative, and general symptoms of schizophrenia, schizophreniform disorder and schizoaffective disorder, cognitive deficits associated with schizophrenia, co-morbid depressive and anxiety symptoms, functional outcome, overall severity of the illness and relapse rates. The safety and tolerability of long-acting injectable risperidone will also be assessed.

Patients randomized to the risperidone long-acting intramuscular injectable formulation will be administered 25 mg of risperidone at Day 1 and subsequent injections will be administered every 2 weeks, with increases made in 12. 5 mg increments as required, to a maximum dose of 50 mg. The study duration is 24 months.

Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis within the past 3 years of schizophrenia, schizophreniform disorder or

schizoaffective disorder, and currently being treated with not more than one antipsychotic medication at a dose below the maximum daily CPS guidelines (risperidone 6 mg, olanzapine 20 mg, quetiapine 800 mg) or treatment naïve (not currently being treated)

- PANSS (Positive and Negative Syndrome Scale for Schizophrenia) score of 60-120 at the

Visits 1 and 2

- Patients with a primary diagnosis of schizoaffective disorder are permitted one mood

stabilizer (of which lithium is included) provided they have been on a stable dose for at least 4 weeks prior to screening and are expected to continue on the same medication/dose throughout stabilization period

- Patients with a secondary diagnosis of major depressive disorder are permitted study

entry provided they are on one antidepressant at a stable dose for 4 weeks prior to screening and are expected to continue on the same medication/dose throughout the stabilization period

- Females must be surgically sterile, or practicing an effective method of birth control

before entry and throughout the study and have a negative urine pregnancy test prior to study entry

Exclusion Criteria:

- Have a serious unstable or untreated medical illness or a clinically significant

laboratory abnormality

- Had treatment with a long-acting injectable antipsychotic medication within 3 months

of study start

- Have failed to respond to 2 or more treatment regimens of antipsychotic medications,

known to be a risperidone non-responder, or have a confirmed or suspected history of hypersensitivity or allergy to risperidone

- Patients at significant risk of suicide or violence at study start

- Current drug or alcohol dependence

Starting date: September 2004
Last updated: May 24, 2007