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

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizoaffective Disorder; Psychotic Disorder

Intervention: Placebo (Drug); Paliperidone ER (Drug); Paliperidone ER (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Clinical Details

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Flexible-dose Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.

Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Secondary outcome:

Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline

Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder

Participants With Response

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Ahmedabad, India

Ahmedibad, India

Aurangabad, India

Chennai, India

Delhi, India

Kanpur Uttarpradeh, India

Pune, India

Vadadora, India

Chonju, Korea, Republic of

Daegu, Korea, Republic of

Gyeonggi-Do, Korea, Republic of

Inchun, Korea, Republic of

Kwangiu, Korea, Republic of

Pusan, Korea, Republic of

Seoul, Korea, Republic of

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

Campina, Romania

Com Gura Ocnitei, Romania

Iasi, Romania

Pitesti, Romania

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

Additional Information

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

Starting date: December 2006
Last updated: April 24, 2014

Page last updated: August 23, 2015

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