Subjects 18 – 65 years of age, who meets the DSM-IV criteria for schizophrenia with a PANSS total score at screening of 60-100 inclusive. MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Trade Name: INVEGA
Product Name: paliperidone 3 mg
Product Code: f039
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: PALIPERIDONE
CAS Number: 144598-75-4
Current Sponsor code: R076
Sponsors
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Male or female, between 18 and 65 years of age, inclusive; ·Subject meets the DSM-IV criteria for schizophrenia; ·Subject has a PANSS total score at screening of 60 to 100, inclusive ·Subject must, in the opinion of the investigator, benefit from treatment with paliperidone ER or olanzapine; ·Subjects on lipid-lowering therapy must be on a stable dose for at least 4 weeks for statins, niacin, ezetimibe and resins or for at least 12 weeks for fibrates. ·Subject is able to read, understand and sign the Institutional Review Board-approved informed consent form; ·Female subjects must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; women of child-bearing potential must have a negative urine pregnancy test at screening; ·Subject is healthy on the basis of a physical examination and vital signs at screening; ·Subject must be able and willing to fill out self-administered questionnaires. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Subject has previously been treated with paliperidone ER, olanzapine, or clozapine within the past 6 months or has never been treated with an antipsychotic before; ·Treatment with a depot antipsychotic within the past 3 months before screening; ·Subject has a history of diabetes or currently receiving a glucose lowering agent to treat diabetes; ·Subject has abnormal fasting plasma glucose (³126 mg/dL) or fasting triglycerides (TG) levels (> 400 mg/dL) at screening; ·Subject has, at the discretion of the investigator, clinically relevant abnormal laboratory values at screening; ·Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, including recent or present clinically relevant laboratory abnormalities (as deemed by the investigator); ·History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including: HR 450 msec, as measured on more than one ECG (either during screening or from prior medical record); the following cardiac conditions: sick sinus syndrome, complete AV block, congestive heart failure, polymorphic ventricular tachycardia; clinically relevant hypocalcemia, hypokalemia or hypomagnesemia; concomitant use of drugs that prolong the QTc interval (including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications); presence of congenital prolongation of the QT interval (Romano-Ward Syndrome, Jervell and Lange-Nielsen syndrome); ·History or current symptoms of tardive dyskinesia; ·History of neuroleptic malignant syndrome; ·Pregnant or breast-feeding female; ·Known hypersensitivity to paliperidone ER, risperidone or olanzapine; ·Judged to be at high risk for or presence of violence or self-harm; ·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); ·Subjects with a narrowing or blockage of their gastro-intestinal tract; ·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 family members of the employees or the investigator; ·Subjects with a current use or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria; ·Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to show that paliperidone is superior to olanzapine in change of the triglyceride to high density lipoprotein ratio (TG:HDL ratio).;Secondary Objective: Secondary objectives are * to evaluate additional metabolic endpoints (Changes in fasting insulin, total cholesterol, HDL, low density lipoproteins (LDL), TG, and glucose, levels; Homeostatic model assessment of b-cell function (HOMA2-%B) and homeostatic model assessment of insulin sensitivity (HOMA2-%S); 75 Oral gram Glucose Tolerance Test to assess insulin sensitivity and changes in insulin secretion as well as glycemic status (Impaired Fasting Glucose, Impaired Glucose Tolerance, Type 2 Diabetes); Changes in weight, BMI and waist; New onset or presence of metabolic syndrome during treatment according to NCEP/ATP III criteria) * to demonstrate non-inferiority of paliperidone ER versus olanzapine in efficacy as measured by Positive and Negative Syndrome Scale (PANSS). * assessing safety ;Primary end point(s): The primary endpoint is defined as a change from baseline to endpoint in the ‘TG:HDL’ ratio. | — |
Countries
Estonia, France, Greece, Italy, Latvia, Lithuania, Spain, Sweden, United Kingdom
Outcome results
None listed