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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03345342




Registration number
NCT03345342
Ethics application status
Date submitted
14/11/2017
Date registered
17/11/2017
Date last updated
15/09/2023

Titles & IDs
Public title
A Study of Paliperidone Palmitate 6-Month Formulation
Scientific title
A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
Secondary ID [1] 0 0
R092670PSY3015
Secondary ID [2] 0 0
CR108390
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PP6M
Treatment: Drugs - PP3M 350 mg eq.
Treatment: Drugs - PP3M 525 mg eq.
Treatment: Drugs - PP1M
Other interventions - Placebo

Experimental: PP1M: Transition Phase - Participants who previously have not achieved stability with moderate to higher doses of Paliperidone palmitate 1-month (PP1M) or Paliperidone palmitate 3-month (PP3M) will enter into a transition period of up to 4 months. During transition period participants will receive 1 to 5 injections of PP1M 50 to 100 milligrams equivalent (mg eq.). The participants who achieved stability (stability is defined as at least 3 months of injections with the last 2 doses being the same strength) with PP1M 100 mg eq. will precede from transition phase to maintenance phase.

Experimental: PP1M/PP3M: Maintenance Phase - All the participants will receive only 1 dose of PP1M 100 or 150 mg eq. or PP3M 350 or 525 mg eq. The participants will precede from maintenance phase to double-blind phase.

Experimental: PP6M or Placebo: Double-Blind Phase - Participants will receive intramuscular injection of PP6M in left gluteal muscle on Day 1 and right gluteal muscle on Day 183 with alternating placebo in right gluteal muscle on Day 92 and left gluteal muscle on Day 274.

Experimental: PP3M: Double-Blind Phase - Participants will receive intramuscular injections of PP3M at dose of 350 mg eq. or 525 mg eq. in left gluteal muscle on Day 1 and 274 and right gluteal muscle on Day 92 and 183.


Treatment: Drugs: PP6M
Participants will receive intramuscular injection of PP6M.

Treatment: Drugs: PP3M 350 mg eq.
Participants will receive intramuscular injection of PP3M 350 mg eq.

Treatment: Drugs: PP3M 525 mg eq.
Participants will receive intramuscular injection of PP3M 525 mg eq.

Treatment: Drugs: PP1M
Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.

Other interventions: Placebo
Participants will receive matching placebo.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Relapse During the Double-Blind (DB) Phase
Timepoint [1] 0 0
Up to 12 months of DB Phase
Secondary outcome [1] 0 0
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
Timepoint [1] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [2] 0 0
Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score
Timepoint [2] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [3] 0 0
Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score
Timepoint [3] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [4] 0 0
Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase
Timepoint [4] 0 0
Up to 12 months of DB Phase
Secondary outcome [5] 0 0
Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score
Timepoint [5] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [6] 0 0
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score
Timepoint [6] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [7] 0 0
Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score
Timepoint [7] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [8] 0 0
Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score
Timepoint [8] 0 0
Up to 12 Months of DB Phase
Secondary outcome [9] 0 0
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score
Timepoint [9] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [10] 0 0
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score
Timepoint [10] 0 0
Baseline and endpoint (12 Months of DB Phase)
Secondary outcome [11] 0 0
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase
Timepoint [11] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [12] 0 0
Change From Baseline in the Body Mass Index (BMI) During DB Phase
Timepoint [12] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [13] 0 0
Change From Baseline in the Waist Circumference During DB Phase
Timepoint [13] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [14] 0 0
Change From Baseline in the Body Weight During DB Phase
Timepoint [14] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [15] 0 0
Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase
Timepoint [15] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [16] 0 0
Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase
Timepoint [16] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [17] 0 0
Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase
Timepoint [17] 0 0
Baseline (DB) to 12 Months of DB Phase
Secondary outcome [18] 0 0
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase
Timepoint [18] 0 0
Up to 12 Months of DB Phase
Secondary outcome [19] 0 0
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase
Timepoint [19] 0 0
Up to 12 Months of DB Phase

Eligibility
Key inclusion criteria
- Must meet the diagnostic criteria for schizophrenia according to Diagnostic and
Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months
before screening

- Must be receiving treatment with paliperidone palmitate (as either the paliperidone
palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or
injectable risperidone, or any oral antipsychotic

- Must be able, in the opinion of the investigator, to discontinue any antipsychotic
medication other than PP1M) or PP3M during the Screening Phase

- Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (<)
70 points at screening

- Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)^2
(inclusive) and must have a body weight of at least 47 kg at screening

- Must be willing to receive gluteal injections of medication during the Double-blind
Phase
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Must not be receiving any form of involuntary treatment, such as involuntary
psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment

- Must not have attempted suicide within 12 months before screening and must not be at
imminent risk of suicide or violent behavior, as clinically assessed by the
investigator at the time of screening

- Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except
for nicotine and caffeine) within 6 months of screening; however, acute or
intermittent substance use prior to screening is not exclusionary, depending upon the
clinical judgment of the investigator

- Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia

- Must not have a history of intolerability or severe reactions to moderate or higher
doses of antipsychotic medications and must not have any other factors that would, in
the judgment of the investigator, indicate that treatment with moderate or higher
doses of paliperidone palmitate would be intolerable or unsafe

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/05/2020
Sample size
Target
Accrual to date
Final
841
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 0 0
Neuro Trials Victoria - Noble Park
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
3174 - Noble Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
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New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
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Ohio
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Cordoba
Country [18] 0 0
Argentina
State/province [18] 0 0
La Plata
Country [19] 0 0
Argentina
State/province [19] 0 0
Rosario
Country [20] 0 0
Brazil
State/province [20] 0 0
Curitiba
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Brazil
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Itapira
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Bulgaria
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Bourgas
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Bulgaria
State/province [27] 0 0
Pazardzhik
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Bulgaria
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Plovdiv
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Bulgaria
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Radnevo
Country [30] 0 0
Bulgaria
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Sofia
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Czechia
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Brno
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Czechia
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Hradec Kralove-Vekose
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Czechia
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Plzen
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Czechia
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Prague
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Czechia
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Praha 2
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France
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Bordeaux
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France
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Montpellier
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France
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Nimes Cedex 9
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France
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Paris
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France
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Toulon Cedex
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Gyor
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Hungary
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Kalocsa
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Hungary
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Miskolc
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India
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Ahmedabad
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India
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Chennai
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India
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Hyderabad
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India
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Madurai
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India
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Mangalore
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India
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Manipal
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India
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Pune
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India
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Varanasi
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Italy
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Cagliari
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Italy
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Lecce
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Italy
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Napoli
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Italy
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Roma
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Seoul
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Malaysia
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Ipoh
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Mexico
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Mexico City
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Mexico
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Monterrey
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Mexico
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San Luis Potosí
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Bialystok
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Chelmno
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Gdansk
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Gorlice
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Leszno
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Lublin
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Pruszcz Gdanski
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Pruszkow
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Poland
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Torun
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Russian Federation
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Ekaterinburg
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Russian Federation
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Moscow
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Russian Federation
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Nizny Novgorod
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Russian Federation
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Saratov
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Russian Federation
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St-Petersburg
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Russian Federation
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St.Peterburg
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Russian Federation
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Tomsk
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South Africa
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Cape Town
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South Africa
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Pretoria
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South Africa
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Welgemoed
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Oviedo
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Spain
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Ponferrada
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Spain
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Valencia
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Spain
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Zamora
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
State/province [96] 0 0
Ankara
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Turkey
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Istanbul
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Turkey
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Konya
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Turkey
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Sakarya
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Ukraine
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Glevakha
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Ukraine
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Kharkiv
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Ukraine
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Kherson
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Oleksandrivka
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Ukraine
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Smila
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Ukraine
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Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate that injection cycles consisting of a single
administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2
sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg
eq.) for the prevention of relapse in participants with schizophrenia previously stabilized
on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M
(350 or 525 mg eq.).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03345342
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries