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3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on 3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia Clinical research trials and 3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including 3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia. 3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a 3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia clinical trial. Participants typically obtain the most effective healthcare available for their 3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "3" Clinical Trials Conditions > 3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia  3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia
3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia
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 extended release (ER) OROS paliperidone (6, 9, and 12 mg/day) compared with placebo in subjects with schizophrenia. The efficacy response will be measured by the change in the Positive and Negative Syndrome Scale (PANSS) total score from start of treatment to the end of double blind phase.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Double-Blind phase: - Subjects can be male or female - Age must be 18 years or older - Subjects must have been diagnosed with shizophrenia according to DSM - IV (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening - Subjects 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. - Subjects must be experiencing an acute episode, with a total PANSS score at screening between 70 and 120. - Female subjects of child-bearing potential must agree to use an acceptable form of contraception (e.g., prescription oral contraceptives patch, male partner sterilization) before entry and thorought the study, and must have a negative serum b-human chorionic gonadotropin (b-hCG) pregnancy test at screening. - Subjects must agree to voluntary hospitalization for a minimum of 14 days. - Subjects must be willing and able to fill out self administered questionnaires. - Subjects must be able to be compliant with self-administration of medication, or have consistent help/support available. Open Label Extension phase: - Subjects must have signed the Informed Consent Form for the open-label phase. - Subjects 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. - Subjects and investigator must agree that open-label treatment is in the best interest of the subjects. - Female subjects of child-bearing potential must agree to use an acceptable form of contraception (e.g., prescription oral contraceptives patch, male partner sterilization) throughout the open-label extension and must have a negative urine pregnancy test at open-label baseline. Exclusion Criteria Double-blind phase: - A DSM-IV axis I diagnosis other than schizophrenia - A DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary) - Any medical condition that could potentially alter the absorbtion, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renaldisease. - Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases - History of tardive dyskinesia or neuroleptic malignant syndrome (NMS) - Known allergic reaction (rash)to phenytoin, carbamazepine, barbiturantes, lamotrigine - Other significant and/or unstable systemic illnesses - Allergy or hypersensitivity to risperidone, paliperidone, or olanzapine - History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) - Inability to swallow the study medication whole with the aid of water(subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile) - Previous history of lack of response (2 adequate trials) to any antipsychotic - Exposure to an experimental drug or experimental medical device within 90 days before screening - Significant risk of suicidal or viloent behavior - Female subjects who are pregnant or breastfeeding - Alanine aminotransferase or aspartate aminotranferase levels more than 2 times the upper limit of normal - Other biochemistry, hematology, or urinalysis results that are not within the laboratory's reference range, and that are deemed by the investigator to be clinically significant - Use of beta-blockers (if used for any indication other than hypertension and still present at baseline) - Injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening - Use of monoamine oxidase inhibitors within 4 weeks before screening - Use of another antidepressants (unless subject has been on a stable dosage for at least 3 months prior to screening) or mood stabilizers (e.g., antiepileptics, lithium) within 2 weeks before screening - Received electroconvulsive therapy within 3 months before screening - Employees of the investigator or study center, persons with direct involvment in the proposed study or other studies under the direction of the investigator or study center, or family members of the employees or the investigator Open-Lable Phase: - Subjects believed by the investigator to be at significant risk for suicidal or violent behaviour during the open-label extension - Female subjects who have become pregnant - Subjects who have received an injection of a depot antipsychotic since entry into the preceding double-blind phase
Total Enrollment: 595
Location and Contact Information:
De Veen R.C.A *Recruiting*
ENSCHEDE, , 7546TA
Netherlands
Recruiting R.C.A. VEEN 0534881881
Additional Information:
Study ID Numbers: R076477-SCH-303/ 703;
Study Start Date: March 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078039
Other Schizophrenia Studies:
1. The Assessment of a weight-gain agent for the Treatment of Olanzapine-Associated Anti-obesity Agent in Patients with Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
2. Trial of D-Cycloserine in Schizophrenia
3. Improving Health Services for Veterans with Schizophrenia
4. Antidepressant Treatment in Late Life Schizophrenia
5. Schizophrenia Study
Related Studies:
Other Schizophrenia Clinical Trials
Other Clinical Trials
Other ENSCHEDE Clinical Trials
3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia
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