A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia

NCT01051531 | Completed Phase 3

• 2 other identifiers: CR016522R092670SCH3009
• Study Type: interventional
• Target: 546
• Locations: 9 countries
• Sites: 41

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; R092670; Paliperidone palmitate; Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; Intramuscular injection

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (5)

• 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

  5 visits (Day 1, day 38, day 188, day 368 and day 548)

• 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

  9 visits (Day 1, day 8, day 38, day 98, day 188, day 278, day 368, day458 and day 548)

• The changes in total PANSS score and PANSS sub-domains/symptom factors

  5 visits (Day 1, day 38, day 188, day 368 and day 548).

• Safety measures (laboratories, adverse events, ESRS-A)

  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)

• Assessment of healthcare resource utilization

  7 visits (Day -7, Day 98, day 188, day 278, day 368, day 458 and day 548)

Study Arms (1)

Paliperidone palmitate

EXPERIMENTAL

Drug: Paliperidone palmitate

Interventions

Paliperidone palmitate DRUG

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.

Paliperidone palmitate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (41)

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Dandenong, Australia

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Elizabeth Vale, Australia

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Epping, Australia

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Frankston, Australia

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Glenside, Australia

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Heidelberg, Australia

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Melbourne, Australia

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Prahran, Australia

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Westmead, Australia

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Beijing, China

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Guangzhou, China

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Nanjing, China

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Shanghai, China

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Xi'an, China

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Hong Kong, Hong Kong

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Johor Bahru, Malaysia

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Kota Bharu, Malaysia

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Kota Kinabalu, Malaysia

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Kuala Lumpur, Malaysia

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Kuching, Malaysia

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Tanjong Rambutan, Malaysia

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Terengganu, Malaysia

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Auckland, New Zealand

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Pasig, Philippines

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Pasig National Capitol Region, Philippines

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Busan, South Korea

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Daegu, South Korea

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Daejeon, South Korea

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Gwangju, South Korea

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Gyeonggi-do, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Changhua County, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Bangkok, Thailand

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Khon Kaen, Thailand

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Songkhla, Thailand

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Ubon Ratchathani, Thailand

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Related Links

• Safety, Tolerability, and Treatment Response of Paliperidone Palmitate in Subjects with Schizophrenia When Switching from Oral Antipsychotics

MeSH Terms

Conditions

Schizophrenia; Disease

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 18, 2010
• Study Start: April 22, 2010
• Primary Completion: May 17, 2013
• Study Completion: May 17, 2013
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

PH (2); CN (5); KR (7); TW (5); HK (1); MY (7); NZ (1); TH (4); AU (9)