Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate

Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate - A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Paliperidone palmitate

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Porto Alegre, Brazil
  • Riberao Preto, Brazil
  • Sao Jose, Brazil
  • Sao Paulo, Brazil
• Colombia
  • Barranquilla, Colombia
  • Bogota, Colombia
  • Bucarmanga, Colombia
  • Medellin, Colombia
• Mexico
  • Acapulco, Mexico
  • Guadalajara, Mexico
  • Mexico, Mexico
  • Monterrey, Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Positive and Negative Syndrome Scale (PANSS)	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).	Baseline to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in global severity of illness using the clinical global impression - severity (CGI-S) scores	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).	Baseline to 4 months
Change from Baseline in the personal and social performance scale (PSP)	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..	Baseline to 4 months

Collaborators and Investigators

• Sponsor: Janssen-Cilag Farmaceutica Ltda.
• Investigators: Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

Helpful Links

• Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate - A Pilot Study

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 6, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Schizophrenia; Paliperidone palmitate; Long-acting injectable antipsychotic medication
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: CR017977; R092670SCH3012 (Other Identifier: Janssen-Cilag Farmaceutica Ltda.)