Status:
COMPLETED
Injection Site Tolerability of Multiple Dose Treatment With Long-acting Injectable Risperidone Administered Via Deltoid Muscle in Chronic Schizophrenia Patients.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
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 antipsychoti...
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 cl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00828958
Start Date
February 1 2006
End Date
September 1 2006
Last Update
May 18 2011
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