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Intramuscular Injections of Risperidone 4-Week Long-Acting Injectable (LAI) Formulation in the Buttock of Subjects With Schizophrenia
This study is currently recruiting participants.
Study NCT00821600.   Last updated on January 13, 2009.
Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Intramuscular Injections of Risperidone 4-Week Long-Acting Injectable (LAI) Formulation in the Buttock of Subjects With Schizophrenia
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 Subjects With Chronic Stable Schizophrenia

The purpose of this study is to explore the pharmacokinetics, safety and tolerability of a 4-week LAI formulation of risperidone after single injection of 1 mg IR risperidone and single i.m. injection of 75 mg risperidone LAI in the gluteal muscle Risperidone is an antipsychotic medication for patients with schizophrenia.

An intramuscular (i.m.) 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 given every 4 weeks in patients with chronic stable schizophrenia. As this formulation is a long acting formulation, subjects will be treated with a 1 mg immediate release formulation in the first week to confirm that the subject does not develop an allergic reaction to the long acting formulation. Each subject receives a total of two injections. The first one is the immediate release formulation and the second one the new long acting formulation. Eligible subjects can stay on their previous oral medication, no tapering of drugs is needed. Whole blood samples will be collected for the determination of risperidone and 9-hydroxy-risperidone concentrations in plasma. Whole blood samples will be obtained by venipuncture (needle stick) immediately before (pre-dose) and at 5, 10, 20, 30, 45 min, 1, 1.5, 2, 4, 6, 8,12, 16, 24, 36, 48, 72, 96 hours after the 1st injection and at 2, 6, 12, 24, 48, 96 hrs, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 39, 43, 50, 57, 64, 71, 78, 85 days after the 2nd injection of risperidone. Safety will assessed at limited visits throughout the study by monitoring scores of the Clinical Global Impression - Severity (using CGI-S, a scale used by a clinician to rate the severity of the patient's illness); adverse events; changes in clinical laboratory results; extrapyramidal symptoms (ie. neurological side effects of antipsychotic medications) will be evaluated using the Extrapyramidal Symptom Rating Scale (ESRS); physical examinations; electrocardiograms (ECGs); and patient + investigator evaluation of the injection site.

The study has two periods. In the first period all patients will receive one injection of 1 mg risperidone IR (immediate release) solution (liquid). The follow-up duration is 96 hours. In the second period, patients will receive one injection of risperidone 4-week formulation of 75 mg. The follow-up duration is 85 days. The injections in Period 1 and Period 2 will be given in the buttocks muscle (upper, outer side near the hip), separated by a 7 to 14 day wash-out period.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
To explore the pharmacokinetics of a 4-week LAI formulation of risperidone after single i.m. injection of 75 mg in the gluteal muscle.
To evaluate the safety and tolerability of a 4-week LAI formulation of risperidone after single i.m. injection of 75 mg in the gluteal muscle
Psychotic Disorders
Schizophrenia
Drug: risperidone 4-week LAI formulation
To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site
 
Recruiting
26
January 2009

Inclusion Criteria:

  • Patients with a diagnosis of schizophrenia
  • Clinically stable with no change in current antipsychotic medications
  • Meet PANSS (Positive And Negative Syndrome Score) and CGI score (Clinical Global Impressions) 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 electrocardiogram (ECG)
Both
18 Years to 55 Years
No
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com
United States
 
NCT00821600
CR015742
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
January 2009
January 9, 2009
January 13, 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.