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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pte Ltd
ClinicalTrials.gov Identifier:
NCT01051531
First received: January 7, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone palmitate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Treatment Response of Paliperidone Palmitate in Subjects With Schizophrenia When Switching From Oral Antipsychotics

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pte Ltd:

Primary Outcome Measures:
  • 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 [ Time Frame: Treatment response will be evaluated at 5 times during the study (Day 1, day 38, day 98, day 188, day 368 and day 548). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 5 visits (Day 1, day 38, day 188, day 368 and day 548) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 9 visits (Day 1, day 8, day 38, day 98, day 188, day 278, day 368, day458 and day 548) ] [ Designated as safety issue: No ]
  • The changes in total PANSS score and PANSS sub-domains/symptom factors [ Time Frame: 5 visits (Day 1, day 38, day 188, day 368 and day 548). ] [ Designated as safety issue: No ]
  • Safety measures (laboratories, adverse events, ESRS-A) [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Assessment of healthcare resource utilization [ Time Frame: 7 visits (Day -7, Day 98, day 188, day 278, day 368, day 458 and day 548) ] [ Designated as safety issue: No ]

Enrollment: 546
Study Start Date: April 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone palmitate Drug: 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.

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  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051531

  Show 42 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pte Ltd
Investigators
Study Director: Johnson & Johnson Pte. Ltd. Clinical Trial Johnson & Johnson Pte Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pte Ltd
ClinicalTrials.gov Identifier: NCT01051531     History of Changes
Other Study ID Numbers: CR016522, R092670SCH3009
Study First Received: January 7, 2010
Last Updated: March 27, 2014
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
China: Ethics Committee
China: Ministry of Health
China: Food and Drug Administration
Hong Kong: Department of Health
Hong Kong: Ethics Committee
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Thailand: Ministry of Public Health
Korea: Food and Drug Administration
Malaysia: Ministry of Health
New Zealand: Food Safety Authority
New Zealand: Health Research Council
New Zealand: Health and Disability Ethics Committees
New Zealand: Institutional Review Board
New Zealand: Medsafe
Philippines: Department of Health
Philippines: Bureau of Food and Drugs
South Korea: Institutional Review Board

Keywords provided by Johnson & Johnson Pte Ltd:
Schizophrenia
R092670
Paliperidone palmitate
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition
Intramuscular injection

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 26, 2014