Trial Evaluating Three Fixed Dosages of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia

NCT00078039 | Completed Phase 3

• 1 other identifier: CR003379
• Study Type: interventional
• Target: 630
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the double blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (6, 9, and 12 mg/day) compared with placebo in adult patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia, paliperidone

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total PANSS score to the end of the double-blind phase.

Secondary Outcomes (1)

• Assessment of global improvement in severity of illness; Evaluations of the benefits to quality of life; Assessment of the benefits to personal and social functioning. Incidence of adverse events throughout study.

Interventions

Paliperidone ER DRUG

Eligibility Criteria

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

You may qualify if:

• Double-blind phase: DSM-IV diagnosis of schizophrenia at least 1 year prior to screening
• experiencing an acute episode, with a total PANSS score at screening between 70 and 120
• agree to voluntary hospitalization for a minimum of 14 days
• willing and able to fill out self-administered questionnaires
• able to be compliant with self-administration of medication, or have consistent help/support available.
• Open-label extension phase: completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy
• patient and investigator agree that open-label treatment is in the best interest of the patient.

You may not qualify if:

• Double-blind phase: DSM-IV axis I diagnosis other than schizophrenia
• history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
• history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
• previous history of lack of response (2 adequate trials) to any antipsychotic
• significant risk of suicidal or violent behavior. Open-label phase: At significant risk for suicidal or violent behavior
• received an injection of a depot antipsychotic since entry into the preceding double-blind phase.

Sponsors & Collaborators

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

Related Publications (1)

• Meltzer HY, Bobo WV, Nuamah IF, Lane R, Hough D, Kramer M, Eerdekens M. Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. J Clin Psychiatry. 2008 May;69(5):817-29. doi: 10.4088/jcp.v69n0515.

  PMID: 18466043 DERIVED

Related Links

• Trial Evaluating Three Fixed Dosages of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of 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

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 17, 2004
• First Posted: March 12, 2004
• Study Start: March 1, 2004
• Study Completion: January 1, 2005
• Last Updated: June 8, 2011

Record last verified: 2010-04