A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia

NCT00645099 | Completed Phase 3 Results

• 2 other identifiers: CR013189R076477SCH3020
• Study Type: interventional
• Target: 462
• Locations: 13 countries
• Sites: 38

Brief Summary

The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients will participate in this study.

Conditions

Schizophrenia

Keywords

Paliperidone ER; Olanzapine; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio)

  Plasma fasting TG and HDL concentrations were measured to determine the TG:HDL ratio.

  Baseline to End Point (up to 6 months)

Secondary Outcomes (18)

• Change From Baseline to End Point in Triglycerides

  Baseline to End Point (up to 6 months)

• Change From Baseline to End Point in High Density Lipoprotein

  Baseline to End Point (up to 6 months)

• Change From Baseline to End Point in Total Cholesterol

  Baseline to End Point (up to 6 months)

• Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT)

  Baseline to End Point (up to 6 months)

• Change From Baseline to End Point in Converted Insulin

  Baseline to End Point (up to 6 months)

Study Arms (2)

001

EXPERIMENTAL

paliperidone ER 6-mg or 9-mg tablet once daily flexible dosing for 6 months

Drug: paliperidone ER

002

ACTIVE COMPARATOR

olanzapine 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months

Drug: olanzapine

Interventions

olanzapine DRUG

10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months

002

paliperidone ER DRUG

6-mg or 9-mg tablet once daily flexible dosing for 6 months

001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient meets the DSM-IV criteria for schizophrenia
• Patient has a PANSS total score at screening of 60 to 100, inclusive
• Patient must, in the opinion of the investigator, benefit from treatment with paliperidone ER or olanzapine
• Patients 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
• Female patients 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
• Patient is healthy on the basis of a physical examination and vital signs at screening

You may not qualify if:

• Patient 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
• Treatment with a mood stabilizer or a recently initiated antidepressant (\<= 3 months)
• Patient has abnormal fasting plasma glucose (\> 126 mg/dL) or fasting triglycerides (TG) levels (\> 400 mg/dL) 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (46)

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Buenos Aires, Argentina

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Córdoba, Argentina

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Mendoza, Argentina

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Alexandria, Egypt

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Cairo, Egypt

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El Banfaig 2 District, Egypt

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Pärnu, Estonia

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Tallinn, Estonia

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Tartu, Estonia

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Allonnes, France

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Bron, France

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Dijon, France

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Limoges, France

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Montberon, France

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Athens, Greece

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Amman, Jordan

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Jelgava, Latvia

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Liepāja, Latvia

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Riga, Latvia

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Sigulda, Latvia

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Strenči, Latvia

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Beirut, Lebanon

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Kaunas, Lithuania

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Vilnius, Lithuania

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Cluj-Napoca, Romania

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Craiova, Romania

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Oradea, Romania

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Sibiu, Romania

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Tg Mures, Romania

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Bratislava, Slovakia

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Michalovce, Slovakia

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Rimavská Sobota, Slovakia

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Cape Town, South Africa

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Johannesburg, South Africa

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A Coruña, Spain

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Alicante, Spain

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Barcelona, Spain

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Elche, Spain

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Madrid, Spain

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Santander, Spain

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Vic, Spain

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Zamora, Spain

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Ankara, Turkey (Türkiye)

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Bursa, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Manisa, Turkey (Türkiye)

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Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine; Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Pyrimidines

Limitations and Caveats

Open-label design

Results Point of Contact

• Title: EMEA Therapeutic Area Leader CNS
• Organization: Janssen-Cilag Germany

+492137955153

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: October 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 8, 2014
• Results First Posted: July 29, 2010

Record last verified: 2014-04

Locations

ZA (2); TU (4); GR (1); JO (1); ES (3); AR (3); FR (5); LA (5); LI (2); EG (3); RO (5); LE (1); SL (3)