NCT00488319

A 6-Month, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5 - 12 mg/Day) in the Treatment of Adolescents (12 to 17 Years of Age) With Schizophrenia

Completed Phase 3 Results posted Last updated 19 December 2016

What this trial tests

Phase 3 trial testing Paliperidone ER in Schizophrenia in 400 participants. Completed in 1 July 2012.

Timeline

1 June 2007

Primary endpoint
1 July 2012

1 July 2012

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	400
Start date	1 June 2007
Primary completion	1 July 2012
Estimated completion	1 July 2012
Sites	53 locations across United States, Belgium, Bulgaria, Estonia, Finland, India, Poland, Romania

Drugs / interventions tested

• Paliperidone ER — full drug profile →

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizophrenic Disorders — all drugs for Schizophrenic Disorders →
• Psychotic Disorders — all drugs for Psychotic Disorders →
• Dementia Praecox — all drugs for Dementia Praecox →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 12 to 17, any sex, with Schizophrenia or Schizophrenic Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability
  Time frame: Up to 2 years
  A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing

Sponsor's own description

The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Realising stratified psychiatry using multidimensional signatures and trajectories.
   Joyce DW, Kehagia AA, Tracy DK, Proctor J, et al · · 2017 · cited 14× · PMID 28100276 · DOI 10.1186/s12967-016-1116-1
2. Evaluation of Potentially Prolactin-Related Adverse Events and Sexual Maturation in Adolescents with Schizophrenia Treated with Paliperidone Extended-Release (ER) for 2 Years: A Post Hoc Analysis of an Open-Label Multicenter Study.
   Gopal S, Lane R, Nuamah I, Copenhaver M, et al · · 2017 · cited 7× · PMID 28660406 · DOI 10.1007/s40263-017-0437-9
3. Cognitive functioning in adolescents with schizophrenia treated with paliperidone extended-release: 6-Month exploratory analysis from an open-label, single-arm safety study.
   Pandina G, Nuamah I, Petersen T, Singh J, et al · · 2020 · cited 4× · PMID 32154123 · DOI 10.1016/j.scog.2020.100173