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.
Sponsor study identifier
Secondary identifiers
interventional
307
6 countries
44
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 15, 2006
Actual (reported)December 18, 2006
Actual (reported)June 2008
Actual (reported)June 2008
Actual (reported)December 9, 2009
Actual (reported)Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Baseline
Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.
Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
Baseline
Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
Baseline
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Placebo for 6 weeks
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
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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
307 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2006
First Posted
December 18, 2006
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
(3-12mg/day in 3 mg/day increments for 6 weeks)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Last Updated
May 9, 2014
Results First Posted
December 9, 2009
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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