A Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
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ClinicalTrials.gov Identifier: NCT00210691 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: November 19, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Risperidone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 273 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Risperidone Depot (Microspheres) in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder |
Study Start Date : | December 1999 |
Actual Study Completion Date : | February 2004 |

- Incidence of adverse events; Injection site evaluation; Extrapyramidal Sympton Rating Scale (ESRS) results at each visit for at least 1 year; Clinical evaluations (physical exams, laboratory tests) will be conducted throughout trial
- Clinical Global Impression Severity of illness subscale (CGI-Severity) at each visit for at least 1 year. SF-36 assessed yearly.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have completed the double-blind study (RIS-USA-121) or withdrawn from that study for safety reasons or due to worsening of condition as determined by results from the CGI
- diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
- otherwise healthy on the basis of physical examination, medical history, electrocardiogram, blood biochemistry and hematology tests, and urinalysis.
Exclusion Criteria:
- Known intolerance, sensitivity, serious adverse events, or unresponsiveness to risperidone
- diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder
- diagnosis of substance abuse or dependence
- use of psychostimulants or an antipsychotic medication other than risperidone
- known disease of the central nervous system (stroke, Parkinson's Disease, Huntington's Disease, Alzheimer's Disease, cancer)
- pregnant or nursing females, or those lacking adequate contraception.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210691
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00210691 History of Changes |
Other Study ID Numbers: |
CR004291 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | November 19, 2010 |
Last Verified: | November 2010 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia intramuscular injection psychotropic agents long-acting risperidone |
Additional relevant MeSH terms:
Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents |