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Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm) Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm) Clinical research trials and Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm) medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm). Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm) Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm) clinical trial. Participants oftentimes recieve the finest healthcare available for their Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm) condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm)  Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm)
Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm)
For Condition: Schizophrenia
Status: Recruiting
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ,
Synopsis: The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of ER OROS paliperidone(3, 9, and 15mg/day) compared with placebo in subjects with schizophrenia. The efficacy response will be mesured by the change in the Positive and Negative Syndrome Scale (PANSS) total score from start of treatment to the end of the double-blind phase.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Double-Blind Phase: 1.Subject can be male or female 2.Age must be between 18 and 65 years of age, both inclusive 3.Subject must have been diagnosed with schizophrenia according to DSM-IV (295.10, 295.20, 295.60, 295.90) at least 1 year prior to screening 4. Subject must have signed an informed consent document, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study 5.Subject must be experiencing an acute episode, with a total PANSS score at screening between 70 and 120 6.Female subjects of child-bearing potential must agree to use an acceptable form of contraception (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study, and must have a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test at screening. 7.Subject must agree to voluntary hospitalization for a minimum of 14 days 8.Subjects must be willing and able to fill out self-administerd questionnaires 8.Subjects must be able to be compliant with self-administration of medication, or have consistent help/support available. - Open-Label Phase 1. Subject must have signed the Informed Consent Form for the open-label phase 2.Subject must have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy 3.Subjects and investigator must agree that open-label treatment is in the best interest of the subjects 4. Female subjects of childbearing potential must agree to continue to use an acceptable form of contraception(e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) through the open label extension, and must have a negative urine pregnancy test at open-label baseline. Exclusion Criteria: - Double-Blind Phase: 1. A DSM-IV axis I diagnosis other than schizophrenia 2. A DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary) 3. Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease , or renal disease 4. Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic(including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases 5. History of tardive dyskinesia or neuroleptic malignant syndrome (NMS) 6. Known allergic reaction(rash) to phenytoin, carbamazepine, barbiturates, lamotrigine 7.Other significant and/or unstable systemic illnesses 8. Allergy or hypersensitivity to risperidone, carbamazepine, barbiturates, lamotrigine 9.History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) 10. Inability to swallow the study medication whole with aid of water(subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile) 11. Previous history of a lack of response (2 adequate trials) to any antipsychotic 12. Exposure to an experimental drug or experimental medical device within 90 days before screening 13. Significant risk of suicidal or violent behaviour 14. Female subjects who are pregnant or breastfeeding 15. Alanine aminotransferase or asparate aminotranferase levels more than 2 times the upper limit of normal 16. Other biochemistry, hematology, or urinalysis results that are not within the labotratory's reference range, and that are deemed by the investigator to be clinically significant 17.Use of beta-blockers (if used for any indication other than hypertension and still present at baseline) 18. Injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening 19. Use of monoamine oxidase inhibitors within 4 weeks before screening 20. Use of other antidepressants(unless subject has been on a stable dosage for at least 3 months prior to screening)or mood stabilizers(e.g. antiepilepics, lithium) within 2 weeks before screening 21.Received electroconvulsive therapy within 3 months before screening 22. Employees of the investigator or study center, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or fmily members of the employees or the investigator -Open-Label Extension: 1.Subjects believed by the investigator to be at significant risk for suicidal or violent behaviour during the open-label extension 2.Female subjects who become pregnant 3.Subject who have received an injection of a depot antipsychotic since entry into the preceding double-blind phase
Total Enrollment: 595
Location and Contact Information:
Lakeridge Health Corp-Oshawa *Recruiting*
Oshawa, Ontario, L1G 2B9
Canada
Recruiting Arshad Majeed 905 433 4341
Odyssey Research Services *Recruiting*
Bismark, North Dakota, 58501
United States
Recruiting Madeline Free 701-250-7355
Additional Information:
Study ID Numbers: R076477-SCH-305/705;
Study Start Date: May 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083668
Other Schizophrenia Studies:
1. A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines
2. Schizophrenia Study
3. Electrophysiology and Blood Flow in Patients with Schizophrenia and Their Siblings
4. Clinical Trial of Tolcapone for Cognition in Schizophrenia
5. Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)
Related Studies:
Other Schizophrenia Clinical Trials
Other North Dakota Clinical Trials
Other Bismark Clinical Trials
Extended Release OROS Paliperidone in treatment of Schizophrenia (double blind, placebo-controlled trial, with Olanzapine arm)
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