A Double-blind, Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in Adolescent Patients

NCT00518323 | Completed Phase 3 Results

• 2 other identifiers: CR002368R076477PSZ3001
• Study Type: interventional
• Target: 201
• Locations: 5 countries
• Sites: 34

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 3 weight-based, fixed-dose groups of paliperidone extended release (ER) compared with placebo in adolescent patients between 12 to 17 years of age, who are diagnosed with schizophrenia. Paliperidone ER is an atypical antipsychotic agent approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults. Patients may be voluntary inpatients or outpatients at the time of the screening visit, but should have returned to their usual living situation by Day 21 of the double-blind treatment phase. The study duration is approximately 10 weeks. Patients who have completed this study or who were discontinued from this study due to lack of efficacy but have completed at least 21 days of double-blind treatment and are expected to benefit from paliperidone treatment, may enter an optional open-label safety study.

Conditions

Schizophrenia

Keywords

Schizophrenia; Antipsychotic

Outcome Measures

Primary Outcomes (1)

• Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study.

  The Positive and Negative Syndrome Scale (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 the end.

  6 weeks

Secondary Outcomes (4)

• Change From Baseline to End Point in Clinical Global Impression-Severity (CGI-S) Scale

  6 weeks

• Change From Baseline to End Point in Children's Global Assessment (CGAS) Score

  6 weeks

• Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.

  6 weeks

• Change From Baseline to End Point in Sleep VAS for Daytime Drowsiness

  6 weeks

Study Arms (4)

001

EXPERIMENTAL

Paliperidone ER 1.5 mg tablet once daily for 6 weeks

Drug: Paliperidone ER

002

EXPERIMENTAL

Paliperidone ER 3 mg or 6 mg tablet once daily for 6 weeks

Drug: Paliperidone ER

003

EXPERIMENTAL

Paliperidone ER 6 mg or 12 mg tablet once daily for 6 weeks

Drug: Paliperidone ER

004

PLACEBO COMPARATOR

Placebo Once daily for 6 weeks

Drug: Placebo

Interventions

Paliperidone ER DRUG

3 mg or 6 mg tablet once daily for 6 weeks

002

Placebo DRUG

Once daily for 6 weeks

004

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Must meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) for 1 year (the diagnosis will be established using the K-SADS-PL, including all supplements)
• Must not be a danger to themselves or others, and must have family support available to be maintained as an outpatient
• Should have had at least 1 adequate treatment with an antipsychotic before participation in this study
• Must have a PANSS score between 60 and 120, inclusive, at screening and baseline
• Weight \>=29 kg

You may not qualify if:

• Meet the DSM-IV criteria at screening for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. Other comorbid disorders e.g., attention-deficit hyperactivity disorder (ADHD) are allowed as long as the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in the investigator's judgment do not require medication
• Mild, moderate, or severe mental retardation (i.e., documented intelligence quotient \[IQ\] \<70) established by previous IQ testing or history
• Women who are pregnant (as confirmed by urine pregnancy test performed at screening or baseline), planning to become pregnant or are nursing
• Have a known or suspected history of seizure disorder, or neuroleptic malignant syndrome, encephalopathic syndrome, tardive dyskinesia, or insulin dependent diabetes mellitus
• Presence of any significant or unstable cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease

Sponsors & Collaborators

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

Study Sites (34)

Unknown Facility

Cerritos, California, United States

Location

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Fountain Valley, 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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Washington D.C., District of Columbia, United States

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Lake Charles, Louisiana, United States

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Boston, Massachusetts, United States

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Cleveland, Ohio, United States

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Portsmouth, Virginia, United States

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Spokane, Washington, United States

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Bangalore, India

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Chennai, India

Location

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Hyderabad, India

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Hyderabad Andra Pradesh, India

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Mangalore, India

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New Delhi, India

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Varanasi, India

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Bucharest, Romania

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Ekaterinburg Na, Russia

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Kazan', Russia

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Moscow, Russia

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Moscow Russia, Russia

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Nizhny Novgorod, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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Smolensk Region N/A, Russia

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Stavropol Na, Russia

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Tomsk Na, Russia

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Yaroslavl, Russia

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Hlevakha, 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

Location

Related Publications (2)

• Sliwa JK, Fu DJ, Bossie CA, Turkoz I, Alphs L. Body mass index and metabolic parameters in patients with schizophrenia during long-term treatment with paliperidone palmitate. BMC Psychiatry. 2014 Feb 22;14:52. doi: 10.1186/1471-244X-14-52.

  PMID: 24559194 DERIVED

• Opler M, Malaspina D, Gopal S, Nuamah I, Savitz AJ, Singh J, Hough D. Effect of parental age on treatment response in adolescents with schizophrenia. Schizophr Res. 2013 Dec;151(1-3):185-90. doi: 10.1016/j.schres.2013.10.001. Epub 2013 Oct 18.

  PMID: 24144440 DERIVED

Related Links

• A double-blind, placebo-controlled study of the safety and efficacy of paliperidone extended release (ER) in the treatment of schizophrenia in adolescent patients

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 about longer-term (ie, \>6 weeks) efficacy and safety in adolescents or in young (\<12 years) children with schizophrenia. Results with doses less than 1.5 mg or more than 12 mg cannot be extrapolated from the data.

Results Point of Contact

• Title: Compound Development Team Leader (CDTL)
• 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: August 16, 2007
• First Posted: August 20, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 16, 2014
• Results First Posted: June 9, 2010

Record last verified: 2010-11

Locations

US (10); IN (7); RU (11); RO (1); UA (5)