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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/NCT01515423




Registration number
NCT01515423
Ethics application status
Date submitted
17/01/2012
Date registered
24/01/2012
Date last updated
2/05/2016

Titles & IDs
Public title
Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
Scientific title
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia
Secondary ID [1] 0 0
R092670PSY3011
Secondary ID [2] 0 0
CR100662
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 - PP3M 175 mg eq.
Treatment: Drugs - PP3M 263 mg eq.
Treatment: Drugs - PP3M 350 mg eq.
Treatment: Drugs - PP3M 525 mg eq.
Treatment: Drugs - Placebo (20% Intralipid)
Treatment: Drugs - PP1M 50 mg eq.
Treatment: Drugs - PP1M 75 mg eq.
Treatment: Drugs - PP1M 100 mg eq.
Treatment: Drugs - PP1M 150 mg eq.

Experimental: Paliperidone palmitate 3-month (PP3M) - A formulation of paliperidone palmitate with a 3-month injection interval

Active Comparator: Paliperidone palmitate 1-month (PP1M) - A formulation of paliperidone palmitate with a 1-month injection interval


Treatment: Drugs: PP3M 175 mg eq.
Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

Treatment: Drugs: PP3M 263 mg eq.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

Treatment: Drugs: PP3M 350 mg eq.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

Treatment: Drugs: PP3M 525 mg eq.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

Treatment: Drugs: Placebo (20% Intralipid)
Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.

Treatment: Drugs: PP1M 50 mg eq.
Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.

Treatment: Drugs: PP1M 75 mg eq.
Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.

Treatment: Drugs: PP1M 100 mg eq.
Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.

Treatment: Drugs: PP1M 150 mg eq.
Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase
Timepoint [1] 0 0
Up to 48 weeks
Secondary outcome [1] 0 0
Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
Timepoint [1] 0 0
DB Baseline (Week 17) and 48 week or DB Endpoint
Secondary outcome [2] 0 0
Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48
Timepoint [2] 0 0
DB Baseline (Week 17) and 48 week or DB Endpoint
Secondary outcome [3] 0 0
Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48
Timepoint [3] 0 0
DB Baseline (Week 17) and 48 week or DB Endpoint
Secondary outcome [4] 0 0
Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria
Timepoint [4] 0 0
Weeks 41 to 65
Secondary outcome [5] 0 0
Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48
Timepoint [5] 0 0
DB Baseline (Week 17) and 48 week or DB Endpoint
Secondary outcome [6] 0 0
Change From Baseline in Marder Factor Subscale Score at Week 48
Timepoint [6] 0 0
DB Baseline (Week 17) and 48 week or DB Endpoint

Eligibility
Key inclusion criteria
- Patients with schizophrenia for more than 1 year and whose symptoms are worsening in
the opinion of the investigator

- A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120

- Signed informed consent

- Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice
an effective method of birth control

- Men must agree to use a double-barrier method of birth control

- Be medically stable on the basis of clinical laboratory tests, physical examination,
medical history, vital signs, and electrocardiogram (ECG)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder,
major depressive disorder, schizoaffective disorder, schizophreniform disorder,
autistic disorder, primary substance-induced psychotic disorder, dementia-related
psychosis

- Relevant history or current presence of any significant or unstable medical
condition(s) determined to be clinically significant by the Investigator (ie, obesity,
diabetes, heart disease etc)

- A diagnosis of substance dependence within 6 months before screening

- History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia

- Clozapine use in the last 2 months when used for treatment-resistant or
treatment-refractory illness

- Clinically significant findings in biochemistry, hematology, ECG or urinalysis results

- Any other disease or condition that, in the opinion of the investigator, would make
participation not in the best interest of the patient or that could prevent, limit, or
confound the protocol-specified assessments

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
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
1429
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Elizabeth Vale
Recruitment hospital [2] 0 0
- Frankston
Recruitment postcode(s) [1] 0 0
- Elizabeth Vale
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment outside Australia
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United States of America
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Arkansas
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Rosario
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Innsbruck
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Assebroek
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Bertrix
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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 a paliperidone palmitate 3 month formulation
(PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the
treatment of patients with schizophrenia who have been stabilized on PP1M.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01515423
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT01515423