Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034775
Status:
COMPLETED
Last Update Posted:
2011-01-10
First Post:
2002-05-02
Brief Title:
A Study to Assess Safety and Tolerabiltiy Associated With a Switch From Oral Antipsychotic Medications to Long-acting Injectable Risperidone in Patients With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Open-Label Trial Exploring A Switching Regimen From Oral Neuroleptics Other Than Risperidone To Risperidone Depot Microspheres
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 milligramsmg every 2 weeks for 12 weeks Investigator may adjust dosage to 375mg or 50 mg maximum or supplement risperidone injections with risperidone tablets 1mg according to symptoms and treatment response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None