Clinical trial NCT00946985: 28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years
Official title: A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate With Oral Risperidone in Adults With Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Risperidone
Risperdal
Paliperidone Palmitate
Invega Sustenna
Lead sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.

Detailed description: This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the efficacy of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years prior to screening. High risk of relapse is defined as having documented occurrence of 3 periods of breakthrough symptoms that required a change in patient care per the investigator's judgment (e.g., increase in dose, addition of a new drug, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, psychiatric hospitalization, etc.) within the previous 24 months, including 1 such period within the previous 6 months. Safety evaluations will include Adverse Event (AE) reporting, hematology and clinical chemistry laboratory tests, vital signs, electrocardiogram (ECG), and evaluations of suicidality and sexual functioning. Patients will receive either paliperidone palmitate 50, 75, 100, or 150 mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8 mg tabs once daily for two years.

Eligibility criteria: Inclusion Criteria:

* Patients must be, in the opinion of the investigator, able to understand the informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), as appropriate
* All patients must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
* Must have a current diagnosis of schizophrenia
* must have had 3 periods of breakthrough symptoms that required a change in patient care as determined by the investigator (e.g. increase in dose, addition of a new drug, hospitalization, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, etc.) within the previous 24 months, including 1 such period within the previous 6 months
* Women must be postmenopausal, surgically sterile, or otherwise be incapable of pregnancy, abstinent, or if sexually active, be practicing a highly effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study
* Women of childbearing potential must have a negative urine pregnancy test at screening
* Patients must be cooperative and reliable, agree to receive regular injections, and be willing/able to adhere to the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

* Patients who are unable to provide their own consent or are involuntarily committed to psychiatric hospitalization
* Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior
* Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
* Patients who are in their first episode of psychosis
* Patients currently meeting criteria for any other Axis I diagnosis except substance abuse or an Axis II diagnosis of Mental Retardation or Borderline Personality Disorder
* Meet the Diagnostic and Statistical Manual of Mental Health Disorders fourth edition (DSM-IV) definition of substance dependence (except for nicotine and caffeine dependence) within 6-months prior to entry
* Patients with known allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to paliperidone palmitate, risperidone, Risperdal®, Risperdal® Consta®, or INVEGA® or its excipients
* Patients who received Long Acting Therapy (LAT) treatment within 2 injection cycles prior to screening
* Women who are pregnant or breast-feeding, or planning to become pregnant.

Primary outcomes:
measure: Time to Relapse During Relapse Prevention Phase
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Garden Grove
country: United States
state: California
city: San Diego
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Kissimmee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Kingsport
country: United States
state: Indiana
city: Lake Charles
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Pittsfield
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Flowood
country: United States
state: Mississippi
city: Creve Coeur
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Brooklyn
country: United States
state: New York
city: Middleburg Heights
country: United States
state: Ohio
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Portsmount
country: United States
state: Virginia
city: Curitiba
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Kazanlak
country: Bulgaria
city: Pleven
country: Bulgaria
city: Radnevo N/A
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Halifax
country: Canada
state: Nova Scotia
city: Sudbury
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Baoding
country: China
city: Beijing
country: China
city: Changsha
country: China
city: Guangzhou
country: China
city: Kunming
country: China
city: Shanghai
country: China
city: Wuhan
country: China
city: Xi'An
country: China
city: Bogota
country: Colombia
city: Kutná Hora 1
country: Czech Republic
city: Olomouc 9
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Praha 8
country: Czech Republic
city: Praha 9
country: Czech Republic
city: Strakonice 1
country: Czech Republic
city: Ahmedabad
country: India
city: Aurangabad
country: India
city: Calicut
country: India
city: Hyderabad
country: India
city: Jaipur
country: India
city: Lucknow Gpo
country: India
city: Mangalore
country: India
city: Pune
country: India
city: Varanasi
country: India
city: Chonju
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggi-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Johor Bahru
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Moscow
country: Russian Federation
city: Nizny Novgorod
country: Russian Federation
city: Samara N/A
country: Russian Federation
city: St Petersburg N/A
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Yaroslavl N/A
country: Russian Federation
city: Kharkov
country: Ukraine
city: Kherson
country: Ukraine
city: Kiev
country: Ukraine
city: Odessa
country: Ukraine
city: Simferopol
country: Ukraine
Study officials:
affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC
name: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: