Status:
COMPLETED
Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Psychotic Disorders
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to explore the pharmacokinetics, safety and tolerability of a 4-week long-acting injectable (LAI) formulation of risperidone after single intramuscular (i.m.) injection of...
Detailed Description
An intramuscular injectable formulation of risperidone long-acting formulation is under development with the aim to provide a sustained and stable level of risperidone during each treatment cycle give...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of schizophrenia
- Clinically stable with no change in current antipsychotic medications
- Meet Positive and Negative Symptom Score (PANSS) and Clinical Global Impression (CGI) score criteria
- Have a body mass index (BMI) between 18 and 35 kilogram (kg)/meter (m)2
- If a woman, is postmenopausal surgically sterile, abstinent, or, if sexually active, is practicing before entry into the study and agrees to practice throughout the study an effective method of birth control
- If a man, agrees to use an adequate contraception method as deemed appropriate by the investigator
Exclusion
- Alcohol or substance dependence, with the exception of nicotine or caffeine dependence
- Involuntarily-committed or unable to provide an informed consent
- Has tardive dyskinesia, History of Neuroleptic Malignant Syndrome
- History of or current clinically significant medical illness
- Treatment with any protocol disallowed therapies
- Clinically significant result from screening laboratory or ECG
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00821600
Start Date
December 1 2008
End Date
June 1 2009
Last Update
May 21 2014
Active Locations (3)
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1
Cerritos, California, United States
2
Santa Ana, California, United States
3
Atlanta, Georgia, United States