Working... Menu

Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate

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: NCT01448720
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Janssen-Cilag Farmaceutica Ltda.

Brief Summary:
The purpose of this study is to explore the efficacy of paliperidone palmitate administered as a once monthly injection in patients with an acute exacerbation of schizophrenia.

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

Detailed Description:
This is an open-label (patients and study staff will know the identity of treatments assigned) study of paliperidone palmitate in patients with acute an exacerbation of schizophrenia. The total duration of the study will be approximately 4 months. Eligible patients without a documented history of exposure to oral risperidone or paliperidone extended-release (ER), or intramuscular (IM) RISPERDAL CONSTA or paliperidone palmitate will receive oral risperidone 1 mg/day or extended release (ER) OROS paliperidone 3 mg/day for at least 3 days before the first injection of the study drug (paliperidone palmitate) for tolerability testing. Paliperidone palmitate will be administered to patients as an intramuscular (IM) injection in the deltoid (upper arm) or gluteal (buttocks) muscle.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate - A Pilot Study
Study Start Date : September 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Paliperidone palmitate Drug: Paliperidone palmitate
Type=exact number, unit=mg, number=150, 100, 75 mg equivalent (eq), form=suspension for injection, route=intramuscular use. One IM injection of 150 mq on Day 1, 100 mg eq. on Day 8 (+/- 4 days), and 75 mg eq. is recommended on Days 36, 64, and 92.

Primary Outcome Measures :
  1. Change in the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline to 4 months ]
    The neuropsychiatric symptoms of schizophrenia will be assessed using the 30-item PANSS, which provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each question is rated on a scale of 1 (absent) to 7 (extreme).

Secondary Outcome Measures :
  1. Change from Baseline in global severity of illness using the clinical global impression - severity (CGI-S) scores [ Time Frame: Baseline to 4 months ]
    The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, the patient will be assessed on severity of mental illness at the time of rating between 1 (not ill) and 7 (extremely severe).

  2. Change from Baseline in the personal and social performance scale (PSP) [ Time Frame: Baseline to 4 months ]
    The PSP scale assesses the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior:(a) socially useful activities, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. A score between 71 and 100 indicates only mild difficulties, and one between 31 and 70 indicates varying degrees of disability. A patient with a score of 30 or less has functioning so poor he or she requires intensive support or supervision..

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be otherwise healthy on the basis of physical examination and vital signs at Screening (Baseline) and have a current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening and no longer than 5 years (early diagnosed patients)
  • Have acute exacerbation of psychosis defined as: less than 4 weeks but more than 4 days, PANSS total score of 70 to 120 (inclusive) at screening (moderate symptomatology), a score of 4 or more (at least moderately ill) at screening on the severity scale of the CGI-S
  • If a woman, before entry she must be postmenopausal for at least 1 year, surgically sterile or abstinent. If sexually active, agree to practice an effective method of birth control before entry and throughout the study as specified in the protocol; If a man is heterosexually active with a woman of childbearing potential, he must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 50 days after receiving the last dose of the study drug

Exclusion Criteria:

  • Has evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months (as determined by medical history, clinical laboratory or electrocardiogram [ECG] results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study
  • The psychiatric diagnosis is due to direct pharmacological effects of a substance (eg, a drug of abuse or medication) or a general medical condition (eg, clinically notable hypothyroidism, delirium)
  • Meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
  • Has history or current symptoms of tardive dyskinesia (involuntary repetitive body movements)
  • Has history of neuroleptic malignant syndrome

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): NCT01448720

Layout table for location information
Porto Alegre, Brazil
Riberao Preto, Brazil
Sao Jose, Brazil
Sao Paulo, Brazil
Barranquilla, Colombia
Bogota, Colombia
Bucarmanga, Colombia
Medellin, Colombia
Acapulco, Mexico
Guadalajara, Mexico
Mexico, Mexico
Monterrey, Mexico
Sponsors and Collaborators
Janssen-Cilag Farmaceutica Ltda.
Layout table for investigator information
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
Layout table for additonal information
Responsible Party: Janssen-Cilag Farmaceutica Ltda. Identifier: NCT01448720     History of Changes
Other Study ID Numbers: CR017977
R092670SCH3012 ( Other Identifier: Janssen-Cilag Farmaceutica Ltda. )
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Janssen-Cilag Farmaceutica Ltda.:
Paliperidone palmitate
Long-acting injectable antipsychotic medication

Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
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