An Open-Label Randomized Trial Comparing Risperidone Long Acting Injection (LAI) With Oral Antipsychotic Care in the Treatment of Early Psychosis - Full Text View

Sponsor:	Janssen-Ortho Inc., Canada
Information provided by:	Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:	NCT00246259

Purpose

The purpose of this exploratory study is to evaluate the effectiveness, safety and tolerability of administering risperidone LAI versus oral antipsychotics in patients with recent onset psychosis

Condition	Intervention	Phase
Schizophrenia Psychotic Disorders	Drug: Risperidone long acting injection Drug: Oral antipsychotic (risperidone, quetiapine, olanzapine)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Randomized Trial Comparing RISPERDALCONSTA With Oral Antipsychotic Care in the Treatment of Early Psychosis

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Risperidone Quetiapine Olanzapine

U.S. FDA Resources

Further study details as provided by Janssen-Ortho Inc., Canada:

Primary Outcome Measures:

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 [ Time Frame: each study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Co-morbid depressive symptoms, symptoms of mania, symptoms of anxiety as measured by the Calgary Depression Scale of Schizophrenia (CDSS), Young Mania Rating Scale (YMRS) and Hamilton Anxiety Scale (HAM-A) scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Relapse Rates [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Cognitive functioning as measured by Trail Making A and B and Controlled Oral Word Association Test (COWAT) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Quality of life and social functioning [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Safety [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment:	77
Study Start Date:	September 2004
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Experimental	Drug: Risperidone long acting injection 25-50 mg i.m. injection every 2 weeks for 24 months
002: Active Comparator	Drug: Oral antipsychotic (risperidone, quetiapine, olanzapine) As per local label. Medication administered daily for 24 months.

Detailed Description:

This exploratory study will examine the safety and effectiveness of risperidone long acting injection (LAI) in patients with early psychosis (less than 3 years after diagnosis). Patients need to have either schizophrenia (a disorder where reality is abnormally interrupted) or schizoaffective disorder (a combination of schizophrenia and mania and/or depression) to be able to take part in this study. Both of these diseases result in the patient being treated with antipsychotic therapy. In this study, patients will either be switched to risperidone LAI or continue on their current atypical antipsychotic. The treatment received is decided by chance (like flipping a coin). Both the patient and their doctor will know which medicine is being given. Patients will receive the study medicine for 24 months (2 years). The patients will visit their doctor for 15-37 times for this study. At visits, patients will be asked questions and may be examined by their doctor. Primary Evaluations will be measured by total symptoms as assessed by the Positive and Negative Syndrome Scale (PANSS), time to relapse, social, occupational and functional outcomes. The safety and tolerability of risperidone LAI will be assessed via vital signs, adverse events, laboratory values and scales to measure movement disorders at each study visit (weeks: 2, 6,10,14,18, 22, 28, 40, 52, 64, 76, 88 and 104).

Patients randomized to risperidone LAI will receive 3 weeks of supplementation with their current oral medication in addition to the initial 25 mg risperidone LAI injection. The dose of risperidone LAI may be increased by increments of 12.5 mg, after a minimum of 6 weeks (3 injections) at the previous dose, to a maximum dose of 50 mg, if the patient has not shown any improvement. Patients randomized to the oral antipsychotic arm will remain on their current antipsychotic.

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inpatients or out-patients
Primary Diagnostic and Statistical Manual of Mental Disorders version IV (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
Currently on monotherapy atypical antipsychotic treatment below local label guidelines or treatment naïve
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
Failed to respond to 2 or more adequate treatment trials of antipsychotics
Laboratory abnormality that is deemed clinically significant by the investigator
Serious, unstable and untreated medical illnesses
At significant risk of suicide or violence at study start
Prior treatment with ECT
Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
Pregnant or breastfeeding
Prior clozapine treatment
Treatment with carbamazepine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246259

Sponsors and Collaborators

Janssen-Ortho Inc., Canada

Investigators

Study Director:

Janssen-Ortho Inc. Clinical Trial

Janssen-Ortho Inc., Canada

More Information

No publications provided

Responsible Party:	Janssen-Ortho Inc. ( Vice President, Medical & Government Affairs )
Study ID Numbers:	CR005959
Study First Received:	October 28, 2005
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00246259 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Janssen-Ortho Inc., Canada:

Schizoaffective disorder
Schizophreniform disorder
Atypical antipsychotics
Long acting injection

Schizophrenia
Recent onset psychosis
Risperidone

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions

Schizophrenia
Serotonin Antagonists
Serotonin Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Dopamine Agents
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010