A Randomized, Double-Blind, Parallel-Group, Comparative Study of FlexibleDoses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-ActingIntramuscular Injection in Subjects with Schizophrenia

• Conditions: Schizophrenia; MedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2006-003560-62-BG
• Lead Sponsor: Janssen-Cilag International N.V., Turnhoutseweg 30, 2340 Beerse, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

Men or women, aged at least 18 years old or the minimum age to provide
informed consent in the jurisdiction in which the study is taking place,
whichever is greater

Meet diagnostic criteria for schizophrenia according to DSM-IV
(disorganized type [295.10], catatonic type [295.20], paranoid type
[295.30], residual type [295.60], or undifferentiated type [295.90]) for at
least 1 year before screening

A total PANSS score between 60 and 120, inclusive, at screening and
baseline

Body mass index (BMI) at the screening visit BMI .17 kg/m2

Female subjects must be postmenopausal for at least 2 years, surgically
sterile, abstinent, or, if sexually active, be practicing an effective method
of birth control before study entry and throughout the study. Effective
methods of birth control include contraceptive pills, coil, depot injection
of gestagen, subdermal implantation, hormonal vaginal ring, and
transdermal depot patches. Women of childbearing potential must have a
negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy
test result at screening.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unable to provide their own consent or involuntarily committed to
psychiatric hospitalization

A primary, active DSM-IV diagnosis on Axis I other than schizophrenia

A DSM-IV diagnosis of active substance dependence within 3 months
before screening (nicotine and caffeine are not exclusionary)

History of treatment resistance as defined by failure to respond to
2 adequate treatments with different antipsychotic medications (an
adequate treatment is defined as a minimum of 6 weeks at maximum
tolerated dosage)

Relevant history or current presence of any significant or unstable
cardiovascular, respiratory, neurologic (including seizures or significant
cerebrovascular disease), renal, hepatic, hematologic, endocrine,
immunologic, morbid obesity (BMI >40 kg/m2), or other systemic disease

History of any severe pre-existing gastrointestinal narrowing (pathologic
or iatrogenic) or inability to swallow oral study drug whole with the aid of
water (applies to those subjects requiring oral tolerability only)

Serum chemistry, hematology, or urinalysis results that are not within the
laboratory’s normal reference range and are deemed to be clinically
significant by the investigator

History or evidence of clinically significant hepatic disease [including
aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
>2 times the upper limit of normal] at screening

History of neuroleptic malignant syndrome (NMS)

Significant risk of suicidal or violent behavior, as clinically assessed by
the investigator

Subjects who have participated in 2 or more clinical trials in the past year,
or in 1 clinical trial in the past 6 months (non-intervention, observational,
and retrospective studies excluded)

History of any active malignancy within previous 5 years, with the exception of basal cell carcinomas.

Women who are pregnant or nursing, or is planning to become pregnant during the trial.

Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of the investigator or study center, as well as family members of the employees or the investigator

History of disallowed therapies:
An injectable antipsychotic within 1 injection interval before screening.
clozapine within 3 months before baseline
Risperidone LAI injection within 6 weeks before screeningprevious injection of paliperidone palmitate within past 10 months
Electroconvulsive therapy (ECT) within 60 days before screening
Nonselective/irreversible MAOI antidepressants within 30 days before screening

The following types of medications are not permitted during the double blind and should be washed out by Day –1, (protocol guideline for washout is 5 times the elimination half life):

Mood stabilizers, including lithium and all anticonvulsants
Antiparkinsonian medication
Beta Blockers
other prescription, OTC or herbal agents with psychoactive properties

History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death in association with the use of drugs that prolong the QTc interval, including:

Heart rate <50 beats per minute
Demonstration of repeated prolonged QTc Fridericia interval >450 ms,as measured on more than one ECG (either during screening, or from prior medical records)
The following cardiac conditions: sick sinus syndrome, complete atrioventricular block, congestive heart failure, polymorphic ventricular tachycardia
Clinically relevant hypocalcemia, hypokalem

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified