Clinical trial NCT02713282: A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation
Official title: A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
R092670
Paliperidone Palmitate
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.

Detailed description: This is an international, multicenter (study conducted at multiple sites) study designed to estimate remission rates and assess treatment response, tolerability, and patterns of use of Paliperidone Palmitate 3-Month Formulation (PP3M) in a diverse population of participants with schizophrenia. The study will consist of a screening phase (Day -7 to Day 1), a 52-week, open-label, flexible-dose PP3M treatment phase and a follow up safety assessment 3 months ( +/-14 days ) after the month 12 visit or early discontinuation. Participants' Safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia
* Able to read, understand, and sign the informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
* Willing and able to fill out self-administered questionnaires
* Willing and able to adhere to the prohibitions and restrictions specified in the protocol
* A woman of childbearing potential must have a negative urine pregnancy test at Screening and baseline
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug

Exclusion Criteria:

* His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder)
* Experienced intolerable side effects during treatment with paliperidone palmitate 1-month formulation (PP1M)
* Has a known hypersensitivity to paliperidone or risperidone
* Has received any other long-acting injectable antipsychotic medication other than PP1M within the last 4 months before the first injection of the study drug paliperidone palmitate 3-month formulation (PP3M)
* Has received clozapine during the last 3 months before the Screening visit
* Is considered to be at imminent risk of suicide, even after clinical intervention
* Has a serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
* Has a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
* Is a woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of PP3M
* Has participated in an investigational drug trial in the 30 days prior to the Screening visit or is currently enrolled in an investigational study
* Has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, autistic disorder, or intellectual disabilities and/or meets the DSM-5 definition of severe substance use disorder (except for nicotine and caffeine) within 6 months prior to screening; however, participants with mild or moderate substance use disorder, with the exception of intravenous drug use, will be eligible for enrollment

Primary outcomes:
measure: Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS)
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS) at Month 6, 9 and 12
timeFrame: Month 6, Month 9 , and Month 12
measure: Time to Symptomatic Remission
timeFrame: Up to Month 12
measure: Percentage of Participants who Meet the Remission Severity Criteria
timeFrame: Up to Month 12
measure: Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF)
timeFrame: Up to Month 12
measure: The proportion of subjects with PANSS response
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Rijeka
country: Croatia
city: Zagreb
country: Croatia
city: Esbjerg
country: Denmark
city: Clermont Ferrand
country: France
city: Montpellier
country: France
city: Paris
country: France
city: Rennes
country: France
city: Toulon
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Oranienburg
country: Germany
city: Stralsund
country: Germany
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Nea Kifissia
country: Greece
city: Thessaloniki
country: Greece
city: Beer Yaakov
country: Israel
city: Ramat Gan
country: Israel
city: Gwangju
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Ipoh
country: Malaysia
city: Johor Bahru
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Assen
country: Netherlands
city: Groningen
country: Netherlands
city: Moscow
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Jedda
country: Saudi Arabia
city: Bilbao
country: Spain
city: Madrid
country: Spain
city: Oviedo
country: Spain
city: Sabadell
country: Spain
city: Torrevieja
country: Spain
city: Valencia
country: Spain
city: New Taipei City
country: Taiwan
city: Tainan
country: Taiwan
city: Taoyuan
country: Taiwan
city: Ankara
country: Turkey
city: Bursa
country: Turkey
city: Istanbul
country: Turkey
city: Sakarya
country: Turkey
city: Derby
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Reading
country: United Kingdom
Study officials:
affiliation: Janssen-Cilag Limited
name: Janssen-Cilag Limited Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Pungor K, Bozikas VP, Emsley R, Llorca PM, Gopal S, Mathews M, Wooller A, Bergmans P. Stable patients with schizophrenia switched to paliperidone palmitate 3-monthly formulation in a naturalistic setting: impact of patient age and disease duration on outcomes. Ther Adv Psychopharmacol. 2020 Dec 23;10:2045125320981500. doi: 10.1177/2045125320981500. eCollection 2020.