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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01051531




Registration number
NCT01051531
Ethics application status
Date submitted
7/01/2010
Date registered
18/01/2010
Date last updated
28/10/2024

Titles & IDs
Public title
A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia
Scientific title
Safety, Tolerability, and Treatment Response of Paliperidone Palmitate in Subjects With Schizophrenia When Switching From Oral Antipsychotics
Secondary ID [1] 0 0
R092670SCH3009
Secondary ID [2] 0 0
CR016522
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 - Paliperidone palmitate

Experimental: Paliperidone palmitate -


Treatment: Drugs: Paliperidone palmitate
One intramuscular (IM) injection of paliperidone palmitate 150 mg equivalent (eq.) on Day 1, 100 mg eq. on Day 8, and 75 mg eq. on Day 38. Thereafter, one IM injection of paliperidone palmitate 50, 75, 100, or 150 mg eq. once monthly. Doses may be adjusted every 30 days per the clinician's judgment within the dose range of 50 to 150 mg eq.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment response will be evaluated by findings from the PANSS-a 30-item questionnaire that is administered to the patient by a qualified person (ie, rater) to measure the presence/absence and severity of positive and negative symptoms of schizophrenia
Timepoint [1] 0 0
Treatment response will be evaluated at 5 times during the study (Day 1, day 38, day 98, day 188, day 368 and day 548).
Secondary outcome [1] 0 0
The change in personal and social performance (PSP) score and evolution of ratio of mild degree dysfunction, varying degree difficulty, and poor level function based on PSP score after switch to paliperidone palmitate
Timepoint [1] 0 0
5 visits (Day 1, day 38, day 188, day 368 and day 548)
Secondary outcome [2] 0 0
The rate of discontinuation, the rate of patients hospitalized, the total number and mean duration of institutionalizations, the overall score in global severity of illness, symptom remission, and medication satisfaction questionnaire findings
Timepoint [2] 0 0
9 visits (Day 1, day 8, day 38, day 98, day 188, day 278, day 368, day458 and day 548)
Secondary outcome [3] 0 0
The changes in total PANSS score and PANSS sub-domains/symptom factors
Timepoint [3] 0 0
5 visits (Day 1, day 38, day 188, day 368 and day 548).
Secondary outcome [4] 0 0
Safety measures (laboratories, adverse events, ESRS-A)
Timepoint [4] 0 0
Laboratories (Days 1 and 548; Adverse events (Days 1, 8,38,68,98,128,158,188,218,248, 278, 308, 338, 368, 398, 448, 458, 488, 518 and 548) ESRS-A (Days 1, 8, 38, 98, 188, 278, 368, 458 and 548)
Secondary outcome [5] 0 0
Assessment of healthcare resource utilization
Timepoint [5] 0 0
7 visits (Day -7, Day 98, day 188, day 278, day 368, day 458 and day 548)

Eligibility
Key inclusion criteria
* Signed informed consent to participate in the study obtained
* Signed informed consent to participate in the optional pharmacogenomic component of the study obtained (refusal to give consent for the pharmacogenomic component of the study does not exclude a patient from participation in the clinical study)
* Confirmation of diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) within 5 years prior to screening
* Patient is willing and able to fill out self-administered questionnaires during the study
* confirmation that patient has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time before enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The patient's psychiatric diagnosis is due to the direct pharmacological effects of a drug of abuse substance or medication, or is due to a general medical condition (eg, clinically notable hypothyroidism)
* The patient is treatment resistant in the judgment of the investigator
* The patient meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
* The patient has a previously defined hypersensitivity (anaphylaxis-type reaction) to risperidone or paliperidone or excipients
* The patient has received treatment with a long-acting injectable antipsychotic within 3 injection cycles prior to baseline, received clozapine within 3 months prior to screening, received treatment with other investigational agents within 30 days of the screening visit, has participated in more than one investigational drug study in the past 12 months, or has planned use of other investigational drugs during the time frame of the study
* History or current symptoms of tardive dyskinesia, history of neuroleptic malignant syndrome, or evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
22/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/05/2013
Sample size
Target
Accrual to date
Final
546
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Dandenong
Recruitment hospital [2] 0 0
- Elizabeth Vale
Recruitment hospital [3] 0 0
- Epping
Recruitment hospital [4] 0 0
- Frankston
Recruitment hospital [5] 0 0
- Glenside
Recruitment hospital [6] 0 0
- Heidelberg
Recruitment hospital [7] 0 0
- Melbourne
Recruitment hospital [8] 0 0
- Prahran
Recruitment hospital [9] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Dandenong
Recruitment postcode(s) [2] 0 0
- Elizabeth Vale
Recruitment postcode(s) [3] 0 0
- Epping
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment postcode(s) [5] 0 0
- Glenside
Recruitment postcode(s) [6] 0 0
- Heidelberg
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment postcode(s) [8] 0 0
- Prahran
Recruitment postcode(s) [9] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Guangzhou
Country [3] 0 0
China
State/province [3] 0 0
Nanjing
Country [4] 0 0
China
State/province [4] 0 0
Shanghai
Country [5] 0 0
China
State/province [5] 0 0
Xian
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Hong Kong
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Busan
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Daegu
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Daejeon
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Gwangju-Si
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Gyeonggi-Do
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Incheon
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Malaysia
State/province [14] 0 0
Johor Bahru
Country [15] 0 0
Malaysia
State/province [15] 0 0
Kota Bharu
Country [16] 0 0
Malaysia
State/province [16] 0 0
Kota Kinabalu
Country [17] 0 0
Malaysia
State/province [17] 0 0
Kuala Lumpur N/A
Country [18] 0 0
Malaysia
State/province [18] 0 0
Kuala Lumpur
Country [19] 0 0
Malaysia
State/province [19] 0 0
Kuching
Country [20] 0 0
Malaysia
State/province [20] 0 0
Tanjong Rambutan
Country [21] 0 0
Malaysia
State/province [21] 0 0
Terengganu
Country [22] 0 0
New Zealand
State/province [22] 0 0
Auckland
Country [23] 0 0
Philippines
State/province [23] 0 0
Pasig National Capitol Region
Country [24] 0 0
Philippines
State/province [24] 0 0
Pasig
Country [25] 0 0
Taiwan
State/province [25] 0 0
Changhua County
Country [26] 0 0
Taiwan
State/province [26] 0 0
Kaohsiung
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taichung
Country [28] 0 0
Taiwan
State/province [28] 0 0
Tainan
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taipei
Country [30] 0 0
Thailand
State/province [30] 0 0
Bangkok
Country [31] 0 0
Thailand
State/province [31] 0 0
Khon Kaen
Country [32] 0 0
Thailand
State/province [32] 0 0
Songkhla
Country [33] 0 0
Thailand
State/province [33] 0 0
Ubon Ratchathani

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 the study is to evaluate the safety, tolerability and treatment response of paliperidone palmitate administered as once-monthly injections to patients with schizophrenia.
Trial website
https://clinicaltrials.gov/study/NCT01051531
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01051531