A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772393
• Other study ID #: CR108121
• Secondary ID: 2015-004835-10R0
• Status: Recruiting
• Phase: Phase 3
• First received: April 14, 2016
• Last updated: May 11, 2016
• Start date: April 2016
• Est. completion date: March 2018

Study information

• Verified date: May 2016
• Source: Janssen-Cilag Ltd.
• Contact: Use link at the bottom of the page to see if you qualify for an
• Email: JNJ.CT[@]sylogent.com
• Is FDA regulated: No
• Health authority: Denmark: SundhetsstyrelsenFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesGreat Britain: Medicines and Healthcare Products Regulatory AgencyMalaysia: National Pharmaceutical Control Bureau, Ministry of Health MalaysiaRussia: Ministry of Health of the Russian FederationSouth Korea: Ministry of Food and Drug SafetySpain: Agencia Española de Medicamentos y Productos SanitariosTaiwan: Ministry of Health and WelfareTurkey: Turkish Republic Health Ministry
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Paliperidone palmitate 3 month formulation (PP3M)
Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq) up to 525 mg eq based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Countries where clinical trial is conducted

Croatia,  Denmark,  France,  Germany,  Israel,  Korea, Republic of,  Malaysia,  Netherlands,  Russian Federation,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS)	The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.	Month 12	No
Secondary	Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS) at Month 6, 9 and 12	PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. PANSS provides a total score and scores for 3 subscales, positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). Total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity with the achieved intensity level maintained for at least 6 months.	Month 6, Month 9 , and Month 12	No
Secondary	Time to Symptomatic Remission	Time to Symptomatic Remission will be reported. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity with the achieved intensity level maintained for at least 6 months.	Up to Month 12	No
Secondary	Percentage of Participants who Meet the Remission Severity Criteria	Remission severity criteria that is, a score of mild or less [less than or equal to 3] on all selected PANSS items [P1, P2, P3, N1, N4, N6, G5, and G9]) at each time point.	Up to Month 12	No
Secondary	Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF)	Maintained efficacy will be investigated using the Schuirmann's test to test the change at lastobservation-carried-forward (LOCF) endpoint in total PANSS score at endpoint versus baseline with a non-inferiority margin of 5 points on the PANSS scale.	Up to Month 12	No
Secondary	The proportion of subjects with PANSS response	The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.	Up to Month 12	No

External Links

•   To learn how to participate in this trial please click here.