A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects with Schizophrenia

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-006967-22-GB
• Date of registration: 27/07/2007
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
• Public title: A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects with Schizophrenia
• Scientific title: A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects with Schizophrenia
• Date of first enrolment: 30/11/2007
• Target sample size: 456
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006967-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Estonia, France, Greece, Italy, Latvia, Lithuania, Spain, Sweden, United Kingdom

Key inclusion & exclusion 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:
.Treatment with a mood stabilizer or a recently initiated anti-depressant (less than or equal to 3 months)
·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 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 current 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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, and who in the opinion of the investigator will benefit from a treatment with paliperidone ER or olanzapine
MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia

Intervention(s)

Trade Name: INVEGA 3 mg prolonged-release tablets
Product Name: paliperidone 3 mg
Product Code: f039
Pharmaceutical Form: Prolonged-release tablet

Trade Name: INVEGA 6 mg prolonged release tablets
Product Name: paliperidone 6 mg
Product Code: f040
Pharmaceutical Form: Prolonged-release tablet

Trade Name: ZYPREXA
Product Name: OLANZAPINE 5 MG
Pharmaceutical Form: Tablet

Trade Name: ZYPREXA
Product Name: OLANZAPINE 10 MG
Pharmaceutical Form: Tablet

Primary Outcome(s)

Primary end point(s): The primary endpoint is defined as a change from baseline to endpoint in the ‘TG:HDL’ ratio.

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

Secondary ID(s)

2006-006967-22-LT

R076477-SCH-3020