Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia

NCT00590577 | Completed Phase 3 Results

• 2 other identifiers: CR012550R092670PSY3007
• Study Type: interventional
• Target: 652
• Locations: 8 countries
• Sites: 66

Brief Summary

The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. in the deltoid muscle followed by either deltoid or gluteal injections for a total of 13 weeks of treatment as compared with placebo in patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; Long-acting injectable antipsychotic medication

Outcome Measures

Primary Outcomes (1)

• Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 13 or the Last Post-baseline Assessment

  The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.

  Baseline to 13 weeks or the last post-baseline assessment

Secondary Outcomes (2)

• Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 13 or the Last Post-baseline Assessment.

  Baseline to 13 weeks or the last post-baseline assessment

• Change in Clinical Global Impression-Severity (CGI-S) Scores From Baseline to Week 13 or the Last Post-baseline Assessment

  Baseline to 13 weeks or the last post-baseline assessment

Study Arms (4)

001

EXPERIMENTAL

Paliperidone palmitate 25 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8 36 64

Drug: Paliperidone palmitate 25 mg eq.

002

EXPERIMENTAL

Paliperidone palmitate 100 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8 36 64

Drug: Paliperidone palmitate 100 mg eq.

003

EXPERIMENTAL

Paliperidone palmitate 150 mg eq. Paliperidone palmitate 150 mg eq. i.m. Days 1 8 36 64

Drug: Paliperidone palmitate 150 mg eq.

004

PLACEBO COMPARATOR

Placebo Placebo i.m. Days 1 8 36 64

Drug: Placebo

Interventions

Paliperidone palmitate 25 mg eq. DRUG

Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8, 36, 64

001

Paliperidone palmitate 150 mg eq. DRUG

Paliperidone palmitate 150 mg eq. i.m. Days 1, 8, 36, 64

003

Placebo DRUG

Placebo i.m. Days 1, 8, 36, 64

004

Paliperidone palmitate 100 mg eq. DRUG

Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8, 36, 64

002

Eligibility Criteria

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

You may qualify if:

• Met diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) for at least 1 year before screening. Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
• A total PANSS score at screening of between 70 and 120, inclusive and at baseline of between 60 and 120, inclusive
• Body mass index (BMI)
• i.e., \[weight (kg)\]/\[height (m)\]², of \>17.0 kg/m2
• Women must be postmenopausal for at least 2 years, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. Effective methods of birth control include: prescription hormonal contraceptives, intrauterine device, double-barrier method, and male partner sterilization. Women of childbearing potential must have a negative urine pregnancy test at baseline, before receiving a dose of study drug
• Is able and willing to meet or perform study requirements (e.g., answer self-administered questionnaires). If a patient is unable to read the questions, study personnel may read documents and the patient may then mark his or her choice
• Patients in the US must be able to understand spoken English to permit adequate ratings by the blinded central rater

You may not qualify if:

• Primary diagnosis other than schizophrenia
• Patients who are unable to provide their own consent or who are currently involuntarily committed to psychiatric hospitalization
• History of treatment resistance as defined by failure to respond to 2 adequate studies of different antipsychotic medications
• an adequate study is defined as a minimum of 4 weeks at the patient's maximum tolerated dose
• Relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI\>=40), or other systemic disease
• History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
• Biochemistry, hematology or urinalysis test results that are not within the laboratory's normal reference range and are deemed to be clinically significant by the investigator
• History or evidence of clinically significant hepatic disease (including aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 times the upper limit of normal) at screening
• History of neuroleptic malignant syndrome
• Significant risk of suicidal, homicidal or violent ideation or behavior as clinically assessed by the investigator
• History of life threatening allergic reaction to any drug
• Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, Intralipid (placebo) or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, glycerol)
• Exposure to an experimental drug, experimental biologic, or experimental medical device within 6 months before screening or prior randomization into this study
• Enrollment in 2 or more clinical research studies in the previous year or one or more clinical research studies in the previous 6 months (non intervention, observational, and retrospective studies excluded)
• History of any active malignancy within the previous 5 years, with the exception of excised basal cell carcinomas

Sponsors & Collaborators

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

Study Sites (66)

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Anaheim, California, United States

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Cerritos, California, United States

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Escondido, California, United States

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Glendale, California, United States

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La Palma, California, United States

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Los Angeles, California, United States

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National City, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Atlanta, Georgia, United States

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Hoffman Estates, Illinois, United States

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Kingsport, Indiana, United States

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Wichita, Kansas, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Cedarhurst, New York, United States

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New York, New York, United States

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Olean, New York, United States

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Cincinnati, Ohio, United States

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Moore, Oklahoma, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Arlington, Virginia, United States

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Richmond, Virginia, United States

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Johor Bahru, Malaysia

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Kota Bharu, Malaysia

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Kuala Lumpur, Malaysia

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Perak, Malaysia

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Brasov, Romania

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Bucharest, Romania

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Craiova, Romania

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Iași, Romania

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Oradea, Romania

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Sibiu, Romania

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Tg Mures, Romania

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Kazan', Russia

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Lipetsk, Russia

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Moscow Russia, Russia

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Nizny Novgorod, Russia

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Saint Petersburg, Russia

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Samara, Russia

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St-Petersburg Na, Russia

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St-Petresburg, Russia

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Yaroslavl, Russia

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Belgrade, Serbia

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Kragujevac, Serbia

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Gwangju, South Korea

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Inchun, South Korea

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Seoul, South Korea

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Changhua, Taiwan

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Hualien City, Taiwan

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Kaohsiung City, Taiwan

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Taipei, Taiwan

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Dnipro, Ukraine

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Kharkiv, Ukraine

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Kiev, Ukraine

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Odesa, Ukraine

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Simferopol, Ukraine

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Related Publications (4)

• Alphs L, Bossie CA, Fu DJ, Ma YW, Kern Sliwa J. Onset and persistence of efficacy by symptom domain with long-acting injectable paliperidone palmitate in patients with schizophrenia. Expert Opin Pharmacother. 2014 May;15(7):1029-42. doi: 10.1517/14656566.2014.909409.

  PMID: 24754314 DERIVED

• Bossie CA, Sliwa JK, Ma YW, Fu DJ, Alphs L. Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial. BMC Psychiatry. 2011 May 10;11:79. doi: 10.1186/1471-244X-11-79.

  PMID: 21569242 DERIVED

• Alphs L, Bossie CA, Sliwa JK, Ma YW, Turner N. Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial. Ann Gen Psychiatry. 2011 Apr 11;10(1):12. doi: 10.1186/1744-859X-10-12.

  PMID: 21481243 DERIVED

• Pandina GJ, Lindenmayer JP, Lull J, Lim P, Gopal S, Herben V, Kusumakar V, Yuen E, Palumbo J. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol. 2010 Jun;30(3):235-44. doi: 10.1097/JCP.0b013e3181dd3103.

  PMID: 20473057 DERIVED

Related Links

• Effectiveness and safety of 3 fixed doses (25 mg eq., 100 mg eq., and 150 mg eq.) of paliperidone palmitate in patients with schizophrenia

MeSH Terms

Conditions

Schizophrenia

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

Limitations and Caveats

No information on long-term (ie, more than 13-week) treatment; not designed to detect differences between doses of paliperidone palmitate; not designed to demonstrate efficacy for specific subgroups, such as subjects from a particular country

Results Point of Contact

• Title: Compound Development Team Leader, Paliperidone
• Organization: Johnson & Johnson Pharmaceutical Research & Development

609-730-4530

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 21, 2007
• First Posted: January 10, 2008
• Study Start: March 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 4, 2014
• Results First Posted: October 5, 2009

Record last verified: 2014-05

Locations

UA (5); KR (3); US (32); RO (7); MY (4); SE (2); TW (4); RU (9)