Injection Site Tolerability of Multiple Dose Treatment With Long-acting Injectable Risperidone Administered Via Deltoid Muscle in Chronic Schizophrenia Patients.

Local Site Tolerability of Multiple Dose Treatment With Deltoid Intramuscular Injection of RISPERDAL CONSTA in Subjects With Chronic Schizophrenia.

The purpose of this study is to examine the discontinuation rate of schizophrenia patients receiving multiple sequential 2 mL injections of long acting injectable risperidone (an atypical antipsychotic medication) when administered into the deltoid muscle once every 2 weeks.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Risperidone long-acting injectable

Detailed Description

This is an open-label, multiple-dose, multicenter study in chronic schizophrenia patients, who are receiving long-acting injectable risperidone 25 or 37.5-mg injections into the gluteal muscle, and clinically require a higher dose. The study consists of a pretreatment screening phase, an 8-week, open label treatment phase during which patients will receive 4 sequential 2 mL injections with long-acting injectable risperidone (37.5 or 50 mg) administered every 2 weeks into the deltoid muscle in alternate arms (right versus left) for each visit; and a post treatment phase consisting of end of study evaluations upon completion of all the study procedures on Day 57 or at early withdrawal. The study hypothesis is that repeated injections of long-acting injectable risperidone into the deltoid muscle will be safe and well tolerated as assessed by the percent of patients who discontinue after at least 2 injections. Safety was assessed using adverse events (including occurrence of extrapyramidal symptoms as assessed by the Extrapyramidal Symptoms Rating Scale), clinical laboratory tests (hematology, serum chemistry, urinalysis, and pregnancy testing), vital signs, physical examinations, electrocardiograms, and injection site evaluation. The patients will receive 4 injections with long-acting injectable risperidone (37.5 or 50 mg) administered as 1 injection every 2 weeks into the deltoid muscle.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic schizophrenia of any subtype, according to DSM-IV criteria
• under current treatment with long-acting injectable risperidone 25 mg or 37.5 mg gluteal injections in an adequate study for at least 2 injections, and in need of a dose increase of long-acting injectable risperidone for clinical reason
• informed consent signed by the patient
• patient is otherwise healthy on the basis of a prestudy physical examination and medical history.

Exclusion Criteria:

• No DSM IV Axis I diagnosis other than schizophrenia
• no pregnant or breast feeding women
• no female subject of childbearing potential without adequate contraception
• no history of severe drug allergy or hypersensitivity
• no patients with inadequate mass in the deltoid regions to receive the intramuscular drug injections.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The proportion of patients who discontinued from the study after having received at least 2 deltoid injections will be recorded.

Secondary Outcome Measures

Outcome Measure
Reasons for discontinuation, patient rated local site injection pain and investigator rated local site injection reaction will be assessed at predefined times throughout the study.

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

Helpful Links

• Injection site tolerability of multiple dose treatment with long-acting injectable risperidone administered via deltoid muscle in chronic schizophrenia patients.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 22, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Estimate): May 18, 2011
• Last Update Submitted That Met QC Criteria: May 17, 2011
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: schizophrenia; Risperidone; Long acting injectable; Intradeltoidal injection
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: CR011533