Clinical trial NCT00236587: A Long Term Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia
Official title: An Open Label, Long Term Trial of Risperidone Long Acting Microspheres in the Treatment of Patients Diagnosed With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Intramuscular injection
Antipsychotic agents
Long-acting risperidone
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to document the long term safety of a long-acting injectable formulation of risperidone in the treatment of patients with schizophrenia who have previously been treated with long-acting risperidone. Efficacy will also be evaluated.

Detailed description: This is an open-label, long-term study of a flexible dose of a long-acting injectable formulation of risperidone (risperidone LAI) injected into the muscle at 2 week intervals for at least 12 months in patients diagnosed with schizophrenia. It is an extension of an open label study of patients with schizophrenia (RIS-USA-259) switching from treatment with an oral antipsychotic medication to long-acting injectable risperidone. Safety evaluations include incidence of adverse events, physical examinations, clinical laboratory tests (biochemistry, hematology, and urinalysis), electrocardiograms (ECGs), and Extrapyramidal Symptom Rating Scale (ESRS), a scale for assessing muscle tone, gait, and abnormal movements. Efficacy assessments include measurements using the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the Clinical Global Impression-Severity of Illness scale (CGI-S). Risperidone (25-50milligrams \[mg\]) injections, long-acting formulation, every 2 weeks for at least 1 year. Dosages may be increased (50 mgs maximum) or decreased at discretion of the investigator. Supplementary risperidone tablets (1mg) may be administered.

Eligibility criteria: Inclusion Criteria:

* Completion of RIS-USA-256 within 7 days

Exclusion Criteria:

* History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
* Significant and untreated or unstable medical illness such as diabetes, hypertension, angina
* Serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, neurological system
* Pregnant or nursing females, or those lacking adequate contraception
* Known hypersensitivity or unresponsiveness to risperidone

Primary outcomes:
measure: To accumulate long-term safety data: incidence of adverse events and clinical evaluations (physical examination, Extrapyramidal Symptom Rating Scale [ESRS], laboratory tests, ECGs).
Secondary outcomes:
measure: To evaluate long-term efficacy: Positive and Negative Syndrome Scale for Schizophrenia and the Clinical Global Impression-Severity of Illness subscale (CGI-S) every 3 months, including last visit.
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: