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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.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., January 2009
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Identifier: NCT00821600

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.

Condition Intervention Phase
Psychotic Disorders
Drug: risperidone 4-week LAI formulation
Phase I

MedlinePlus related topics: Psychotic Disorders Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official 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 Subjects With Chronic Stable Schizophrenia

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • To explore the pharmacokinetics of a 4-week LAI formulation of risperidone after single i.m. injection of 75 mg in the gluteal muscle.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 26
Study Start Date: January 2009
Detailed Description:

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 recieves 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.


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 malignant neuroleptic syndrome
  • History of or current clinically significant medical illness
  • Treatment with any protocol disallowed therapies
  • Clinically significant result from screening laboratory or electrocardiogram (ECG)
  Contacts and Locations
Please refer to this study by its identifier: NCT00821600

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:

United States, California
Not yet recruiting
Cerritos, California, United States, 90703
Not yet recruiting
Santa Ana, California, United States, 92701
United States, Georgia
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
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.
  More Information

To learn how to participate in this trial please click here.  This link exits the site

Study ID Numbers: CR015742
Study First Received: January 9, 2009
Last Updated: January 9, 2009 Identifier: NCT00821600  
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
long-acting injectable

Study placed in the following topic categories:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents processed this record on January 13, 2009