Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia
Completed · Phase 1
Conditions studied: Psychotic Disorders, Schizophrenia
In brief
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 75 mg risperidone LAI in the gluteal muscle.
Key facts
- Study ID
- NCT00821600
- Run by
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- People needed
- 24
- Starts
- 2008-12-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2014-05-21
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Cerritos, California, United States
- Study site — Santa Ana, California, United States
- Study site — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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