Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00821600
• Date of registration: 09/01/2009
• Prospective Registration: No
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia
• Scientific title: Single-Dose, Open-Label Pilot Study to Explore the Pharmacokinetics, Safety and Tolerability of a Gluteal Intramuscular Injection of a 4-Week Long-Acting Injectable Formulation of Risperidone in Patients With Chronic Stable Schizophrenia
• Date of first enrolment: December 2008
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00821600
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Psychotic Disorders

Schizophrenia

Intervention(s)

Drug: risperidone IR and LAI formulation

Primary Outcome(s)

To explore the pharmacokinetics of a 4-week long acting injectable (LAI) formulation of risperidone after single intramuscular (IM) injection of 75 mg in the gluteal muscle. [Time Frame: Up to 85 days for 4-week LAI formulation of risperidone and up to 96 hrs for immediate release (IR) formulation]

Secondary Outcome(s)

To explore safety and tolerability of a 4-week LAI formulation of risperidone by monitoring scores on CGI-S, scores on ESRS, AEs, PE, lab values, ECG values and injection site reactions. [Time Frame: Up to 85 days]

Secondary ID(s)

CR015742

Source(s) of Monetary Support

Please refer to primary and secondary sponsors