A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
A Randomized, Double-Blind, Placebo-Controlled, Parellel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder
2 other identifiers
interventional
667
8 countries
80
Brief Summary
This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2010
Typical duration for phase_3
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
January 5, 2015
CompletedJanuary 5, 2015
December 1, 2014
3.1 years
August 30, 2010
December 22, 2014
December 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Double-blind: Percentage of Participants Who Experienced Relapse
Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected positive and negative syndrome scale(PANSS) items to a score of greater than or equal to (\>= 6) after randomization(if the score for the corresponding item was less than or equal to \[\<=\] 4 at randomization); worsening of certain other measures in specific ways at 2 consecutive visits. Relapse by subgroup of participants on monotherapy,adjunctive therapy to antidepressants/mood stabilizers,participants with psychotic symptoms/mood symptoms was examined.
Day 1 up to Month 15 of double blind relapse prevention period
Secondary Outcomes (12)
Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])
Baseline and Week 64 of double blind relapse prevention period
Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
Baseline and Endpoint (Week 64/LOCF) in double-blind period
Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores
Baseline and Endpoint (Week 64/LOCF) in DB period
Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint
Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
- +7 more secondary outcomes
Study Arms (2)
001
EXPERIMENTALpaliperidone palmitate 78 117 156 234 mg (50 75 100 or 150 mg eq.) monthly by i.m. injection for 15 months
002
PLACEBO COMPARATORPlacebo monthly by i.m. injection for 15 months
Interventions
78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months
Eligibility Criteria
You may qualify if:
- DSM-IV diagnosis of schizoaffective disorder
- Experiencing an acute exacerbation of psychotic symptoms
- A score of \>=4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14)
- A score of \>=16 on YMRS and/or a score of \>=16 on the HAM-D-21
- Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
You may not qualify if:
- A primary active mental illness diagnosis other than schizoaffective disorder
- Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior
- Subjects with first episode of psychosis
- Received electroconvulsive therapy in the past 3 months
- History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)
- Received long-acting antipsychotic medication within 2 injection cycles
- Received therapy with clozapine within 3 months
- A history of neuroleptic malignant syndrome
- Previous history of lack of response to antipsychotic medication
- Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose \<30 days prior to screening
- Receiving therapy with carbamazepine
- Receiving therapy with monoamine oxidase inhibitors
- Pregnant, breast-feeding, or planning to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
Unknown Facility
Garden Grove, California, United States
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Oakland, California, United States
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Oceanside, California, United States
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Pico Rivera, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Hollywood, Florida, United States
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Maitland, Florida, United States
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North Miami, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Schamburg, Illinois, United States
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Wichita, Kansas, United States
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Flowood, Mississippi, United States
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Creve Coeur, Missouri, United States
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Cedarhurst, New York, United States
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Staten Island, New York, United States
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Charlotte, North Carolina, United States
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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Ahmedabad, India
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Aurangabad, India
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Chennai, India
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Jaipur, India
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Lucknow Gpo, India
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Mangalore, India
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Mysore, India
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Nashik, India
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Pune, India
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Uttar Pradesh, India
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Vadadora, India
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Varanasi, India
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Vijaywada, India
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Alor Star, Malaysia
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Ipoh, Malaysia
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Kota Bharu, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, Malaysia
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Tanjong Rambutan, Malaysia
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Cebu, Philippines
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Davao City, Philippines
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Iloilo City, Philippines
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Quezon City, Philippines
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Arad, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Oradea, Romania
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Sibiu, Romania
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Timișoara, Romania
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Cape Town, South Africa
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Centurion Gauteng, South Africa
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Durban, South Africa
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George, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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Tyger Valley, South Africa
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Hlevakha, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Poltava, Ukraine
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Simferopol, Ukraine
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Uzhhorod, Ukraine
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Village Stepanovka Kherson, Ukraine
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Vinnitsa, Ukraine
Related Publications (2)
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: 26934062DERIVEDFu DJ, Turkoz I, Simonson RB, Walling DP, Schooler NR, Lindenmayer JP, Canuso CM, Alphs L. Paliperidone palmitate once-monthly reduces risk of relapse of psychotic, depressive, and manic symptoms and maintains functioning in a double-blind, randomized study of schizoaffective disorder. J Clin Psychiatry. 2015 Mar;76(3):253-62. doi: 10.4088/JCP.14m09416.
PMID: 25562685DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Development
- Organization
- Janssen Scientific Affairs, LLC, Titusville, NJ
Study Officials
- STUDY DIRECTOR
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2010
First Posted
September 1, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
January 5, 2015
Results First Posted
January 5, 2015
Record last verified: 2014-12