Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate

NCT01448720 | Completed Phase 3

• 2 other identifiers: CR017977R092670SCH3012
• Study Type: interventional
• Target: 142
• Locations: 3 countries
• Sites: 12

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone palmitate; Long-acting injectable antipsychotic medication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline in global severity of illness using the clinical global impression - severity (CGI-S) scores

  Baseline to 4 months

• Change from Baseline in the personal and social performance scale (PSP)

  Baseline to 4 months

Study Arms (1)

Paliperidone palmitate

EXPERIMENTAL

Drug: Paliperidone palmitate

Interventions

Paliperidone palmitate DRUG

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.

Paliperidone palmitate

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Farmaceutica Ltda.: lead

Study Sites (12)

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Riberao Preto, Brazil

Location

Unknown Facility

São José, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Barranquilla, Colombia

Location

Unknown Facility

Bogotá, Colombia

Location

Unknown Facility

Bucarmanga, Colombia

Location

Unknown Facility

Medellín, Colombia

Location

Unknown Facility

Acapulco, Mexico

Location

Unknown Facility

Guadalajara, Mexico

Location

Unknown Facility

México, Mexico

Location

Unknown Facility

Monterrey, Mexico

Location

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: October 7, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

CO (4); ME (4); BR (4)