Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.

NCT ID: NCT00412373

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-06-30

Brief Summary

The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.

Detailed Description

Schizophrenia and schizoaffective disorder are closely related in terms of symptoms, coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia, treatment with paliperidone extended-release (ER) improved psychotic symptoms, as well as mood symptoms evaluated by anxiety/depression and hostility/excitement Positive and Negative Symptoms of Schizophrenia (PANSS) factor scores. Therefore, paliperidone ER may also be effective in treating symptoms of schizoaffective disorder. Paliperidone's limited potential for drug-drug interaction is particularly important in this patient population, in which multiple drug therapy is relatively common. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo-controlled, parallel-group study is designed to examine the effectiveness and safety of paliperidone ER in adult patients with schizoaffective disorder who are experiencing an acute episode of this disorder. Patients in the study will be randomly assigned to 1 of 2 groups to receive 6 weeks of oral treatment with flexible dosages of paliperidone ER (3-12 mg/day) or with placebo. The primary efficacy outcome will be the change from baseline to Week 6, or the last post-randomization assessment during double-blind treatment (endpoint), in the PANSS total score. Safety will be assessed by monitoring adverse events, clinical laboratory testing, pregnancy testing, vital signs measurements, physical examination, administration of a 12-lead ECG, movement disorders side effect scales, and the InterSePT Scale for Suicidal Thinking. Patients may also choose to participate in a pharmacogenomic (DNA) analysis. The primary study hypothesis is that flexible-dose paliperidone ER is better than placebo on the change from baseline in the PANSS total score in acutely ill patients with schizoaffective disorder. Patients will receive study drug by mouth for a total of 43 days. Beginning on Day 1, patients will take either placebo or paliperidone ER 6 mg/day. After day 4, dosages may be adjusted, at defined intervals, to a dosage between 3 mg/day and 12 mg/day, inclusive.

Conditions

Schizoaffective Disorder; Psychotic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

001

Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)

Group Type: EXPERIMENTAL

Paliperidone ER

Intervention Type: DRUG

(3-12mg/day in 3 mg/day increments for 6 weeks)

003

Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)

Group Type: EXPERIMENTAL

Paliperidone ER

Intervention Type: DRUG

(3-12mg/day in 3 mg/day increments for 6 weeks)

002

Placebo for 6 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

for 6 weeks

Interventions

Placebo

for 6 weeks

Intervention Type: DRUG

Paliperidone ER

(3-12mg/day in 3 mg/day increments for 6 weeks)

Intervention Type: DRUG

Paliperidone ER

(3-12mg/day in 3 mg/day increments for 6 weeks)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder
• A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of >= 60
• A score of >= 16 on Young Mania Rating Scale (YMRS) or a score of >= 16 on the Hamilton Depression Rating Scale (HAM-D 21)

Exclusion Criteria

• A primary active mental illness diagnosis other than schizoaffective disorder
• Patients with first episode psychosis
• Active substance dependence within previous 6 months
• Treatment with clozapine within 6 months of randomization
• A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication
• Pregnancy, breast-feeding, or planning to become pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Cerritos, California, United States

Costa Mesa, California, United States

Garden Grove, California, United States

Huntington Beach, California, United States

Pico Rivera, California, United States

San Diego, California, United States

Aventura, Florida, United States

Hollywood, Florida, United States

Kissimmee, Florida, United States

Leesburg, Florida, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Austin, Texas, United States

Irving, Texas, United States

Ahmedabad, , India

Ahmedibad, , India

Aurangabad, , India

Chennai, , India

Delhi, , India

Kanpur Uttarpradeh, , India

Pune, , India

Vadadora, , India

Ipoh, , Malaysia

Kota Kinabalu, , Malaysia

Kuala Lumpur, , Malaysia

Kuching, , Malaysia

Davao City, , Philippines

Mandaluyong, , Philippines

Manila, , Philippines

Pasig National Capitol Region, , Philippines

Arad, , Romania

Bucharest, , Romania

Câmpina, , Romania

Com Gura Ocnitei, , Romania

Iași, , Romania

Piteşti, , Romania

Daegu, , South Korea

Gyeonggi-do, , South Korea

Inchun, , South Korea

Jeonju, , South Korea

Kwangiu, , South Korea

Pusan, , South Korea

Seoul, , South Korea

Countries

United States; India; Malaysia; Philippines; Romania; South Korea

References

Alphs L, Fu DJ, Turkoz I. Paliperidone for the treatment of schizoaffective disorder. Expert Opin Pharmacother. 2016;17(6):871-83. doi: 10.1517/14656566.2016.1161029. Epub 2016 Mar 24.

Reference Type: DERIVED

PMID: 26934062 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=67&filename=CR013099_CSR.pdf

Evaluation of Effectiveness and Safety of Flexible-Dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.

Other Identifiers

R076477SCA3002

Identifier Type: -

Identifier Source: secondary_id

CR013099

Identifier Type: -

Identifier Source: org_study_id