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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00034775 |
Purpose
The primary purpose of the study is to assess the safety and tolerability of a long-acting injectable formulation of risperidone when switching from an oral antipsychotic in patients with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Psychotic Disorders |
Drug: risperidone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label Trial Exploring A Switching Regimen From Oral Neuroleptics, Other Than Risperidone, To Risperidone Depot Microspheres |
| Enrollment: | 141 |
| Study Start Date: | August 2001 |
| Study Completion Date: | October 2002 |
For schizophrenia patients taking oral antipsychotic medications, a long-acting injectable formulation of a antipsychotic medication may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This is an open-label, non-randomized study of a formulation of risperidone (coated microspheres) injected into the muscle at 2 week intervals over 12 weeks in patients with schizophrenia. The study has two phases: during the first 4 weeks, patients continue treatment with their present medication (haloperidol, quetiapine fumarate, or olanzapine); during the second phase of 12 weeks, patients receive the injectable formulation of risperidone, while continuing to receive their present medication for 3 weeks until the risperidone long-acting injectable reaches effective drug levels. For the remainder of the 12-week treatment phase, patients receive only injectable risperidone every 2 weeks. Safety evaluations include the incidence, type, and severity of treatment-emergent adverse events throughout the study; vital signs (pulse, blood pressure), clinical laboratory tests (hematology, biochemistry, urinalysis), electrocardiograms (ECGs), and extrapyramidial symptoms are also monitored at specified intervals. Assessments of effectiveness include the Positive and Negative Syndrome Scale (PANSS) and overall severity of illness measured by the Clinical Global Impression (CGI) scale. The study hypothesis is that long-acting injectible risperidone will be well-tolerated in the treatment of patients with schizophrenia after switching from treatment with an oral antipsychotic. Risperidone injections (25 milligrams[mg]) every 2 weeks for 12 weeks. Investigator may adjust dosage to 37.5mg or 50 mg (maximum) or supplement risperidone injections with risperidone tablets (1mg), according to symptoms and treatment response.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| ClinicalTrials.gov Identifier: | NCT00034775 History of Changes |
| Other Study ID Numbers: | CR002761 |
| Study First Received: | May 2, 2002 |
| Last Updated: | January 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Schizophrenia intramuscular injection antipsychotic agents risperidone |
|
Psychotic Disorders Mental Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents Risperidone Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents |