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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01051531
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : March 28, 2014
Information provided by (Responsible Party):
Johnson & Johnson Pte Ltd

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Paliperidone palmitate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 546 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Treatment Response of Paliperidone Palmitate in Subjects With Schizophrenia When Switching From Oral Antipsychotics
Study Start Date : April 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 [ 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). ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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). ]
  4. 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) ]
  5. Assessment of healthcare resource utilization [ Time Frame: 7 visits (Day -7, Day 98, day 188, day 278, day 368, day 458 and day 548) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01051531

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Sponsors and Collaborators
Johnson & Johnson Pte Ltd
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Study Director: Johnson & Johnson Pte. Ltd. Clinical Trial Johnson & Johnson Pte Ltd

Additional Information:
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Responsible Party: Johnson & Johnson Pte Ltd Identifier: NCT01051531     History of Changes
Other Study ID Numbers: CR016522
R092670SCH3009 ( Other Identifier: Johnson & Johnson Pte Ltd )
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014

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

Additional relevant MeSH terms:
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Paliperidone Palmitate
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents