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

NCT00412373 | Completed Phase 3 Results

• 2 other identifiers: CR013099R076477SCA3002
• Study Type: interventional
• Target: 307
• Locations: 6 countries
• Sites: 44

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.

Conditions

Schizoaffective Disorder; Psychotic Disorder

Keywords

Schizoaffective Disorder; antipsychotic; paliperidone; placebo

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (12)

• 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.

  Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment

Other Outcomes (4)

• 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

Study Arms (3)

001

EXPERIMENTAL

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

Drug: Paliperidone ER

003

EXPERIMENTAL

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

Drug: Paliperidone ER

002

PLACEBO COMPARATOR

Placebo for 6 weeks

Drug: Placebo

Interventions

Placebo DRUG

for 6 weeks

002

Paliperidone ER DRUG

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

003

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Janssen, LP: collaborator

Study Sites (44)

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Cerritos, California, United States

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Costa Mesa, California, United States

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Garden Grove, California, United States

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Huntington Beach, California, United States

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Pico Rivera, California, United States

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San Diego, California, United States

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Aventura, Florida, United States

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Hollywood, Florida, United States

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Kissimmee, Florida, United States

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Leesburg, Florida, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Irving, Texas, United States

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Ahmedabad, India

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Ahmedibad, India

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Aurangabad, India

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Chennai, India

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Delhi, India

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Kanpur Uttarpradeh, India

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Pune, India

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Vadadora, India

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Ipoh, Malaysia

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Kota Kinabalu, Malaysia

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Kuala Lumpur, Malaysia

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Kuching, Malaysia

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Davao City, Philippines

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Mandaluyong, Philippines

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Manila, Philippines

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Pasig National Capitol Region, Philippines

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Arad, Romania

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Bucharest, Romania

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Câmpina, Romania

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Com Gura Ocnitei, Romania

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Iași, Romania

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Piteşti, Romania

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Daegu, South Korea

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Gyeonggi-do, South Korea

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Inchun, South Korea

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Jeonju, South Korea

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Kwangiu, South Korea

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Pusan, South Korea

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Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26934062 DERIVED

Related Links

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

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Vice President, Medical Affairs, CNS
• Organization: Ortho McNeil Janssen Scientific Affairs, LLC

jhulihan@its.jnj.com

609-730-2136

Study Officials

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

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

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 18, 2006
• Study Start: December 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 9, 2014
• Results First Posted: December 9, 2009

Record last verified: 2014-04

Locations

US (15); RO (6); PH (4); KR (7); MY (4); IN (8)