Clinical trial NCT01926912: A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting
Official title: HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone Palmitate
Hospital setting
Schizophrenic Disorders
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2013-08-21
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with schizophrenia receiving paliperidone palmitate in the hospital setting

Brief summary: The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate use and pattern of paliperidone palmitate usage in participants with schizophrenia in the hospital setting.

Detailed description: This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), multicenter, observational study (a type of study in which participants are observed or certain outcomes are measured). This study will consist of 6-week observational period during which data will be collected for participants who are hospitalized due to schizophrenia exacerbation and are receiving treatment with paliperidone palmitate (treatment initiated within 3 weeks after admission to hospital). The participant satisfaction will be evaluated at week 6 (or early discontinuation). Safety evaluations will include body weight, extrapyramidal symptom (eg, inability to initiate movement and inability to remain motionless) rating scale scores, concomitant therapy and assessment of adverse events.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with schizophrenia
* Participant admitted to hospital due to an exacerbation of their schizophrenia prior to any study-related activity
* Participant may, in the opinion of the participating physician, benefit from treatment with paliperidone palmitate which will be initiated within 3 weeks after admission to hospital

Exclusion Criteria:

* Participant has a known hypersensitivity to paliperidone or risperidone
* Participant has previously been treated with paliperidone palmitate
* Participant has a history of neuroleptic malignant syndrome
* Participant was on clozapine or has previously been treated with any long-acting injectable antipsychotic during the last 3 months

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 6 weeks
measure: Number of participants who discontinue the study due to adverse events
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Change from baseline in Extrapyramidal Symptom Rating Scale (ESRS) score
timeFrame: Baseline, Week 1, Week 2, Week 5, and Week 6
measure: Change from baseline in total Brief Psychiatric Rating Scale (BPRS) score
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
measure: Clinical Global Impression - Severity (CGI-S) scale score
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
measure: Clinical Global Impression - Change (CGI-C) scale score
timeFrame: Week 6
measure: Change from baseline in Personal and Psychosocial functioning (PSP) scale score
timeFrame: Baseline and Week 6
measure: Subject Satisfaction with previous antipsychotic medication (MSQ) scale score
timeFrame: Baseline
measure: Subject Satisfaction with study medication (paliperidone palmitate) scale score
timeFrame: Week 6
measure: Change from baseline in body weight
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Diest
country: Belgium
city: Saint-Servais
country: Belgium
city: Tournai
country: Belgium
city: Pazardjik
country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Targovishte
country: Bulgaria
city: Vratsa
country: Bulgaria
city: Helsingør
country: Denmark
city: Kobenhavn S
country: Denmark
city: Berlin
country: Germany
city: Chemnitz
country: Germany
city: Dresden
country: Germany
city: Greifswald
country: Germany
city: Hamburg
country: Germany
city: Hennigsdorf
country: Germany
city: Neuruppin
country: Germany
city: Pfaffenhofen
country: Germany
city: Sachsen
country: Germany
city: Heraklion Crete
country: Greece
city: Ioannina
country: Greece
city: Katerini Pieria
country: Greece
city: Thessaloniki
country: Greece
city: Bat-Yam
country: Israel
city: Tel Hashomer
country: Israel
city: Almaty
country: Kazakhstan
city: Astana
country: Kazakhstan
city: Kyzylorda
country: Kazakhstan
city: Taraz
country: Kazakhstan
city: Ust-Kamenogorsk
country: Kazakhstan
city: Chelyabinsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Omsk
country: Russian Federation
city: Orenburg, Staritsa Village
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Tula Region
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: