An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia

NCT01299389 | Completed Phase 3 Results

• 2 other identifiers: CR017026PALM-JPN-4
• Study Type: interventional
• Target: 323
• Locations: 3 countries
• Sites: 56

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of paliperidone palmitate as compared with placebo in the treatment of participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions \[a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder\] and hallucinations \[imagining things\], and withdrawal into the self).

Conditions

Schizophrenia

Keywords

Paliperidone palmitate; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation

  The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.

  Baseline and Week 13 or early discontinuation

Secondary Outcomes (6)

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation

  Baseline and Week 13 or early discontinuation

• Participants With Response to the Treatment as Per PANSS Total Score.

  up to Week 13 or early discontinuation

• Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation

  Baseline and Week 13 or early discontinuation (ED)

• Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation

  Baseline and Week 13 or early discontinuation

• Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation

  Baseline and Week 13 or early discontinuation

Study Arms (2)

Paliperidone palmitate

EXPERIMENTAL

Drug: Paliperidone palmitate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Paliperidone palmitate DRUG

Paliperidone palmitate will be given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.

Paliperidone palmitate

Placebo DRUG

Matching Placebo will be given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants meeting Diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision
• Women had to be: postmenopausal (for at least 2 years), surgically sterile (had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (as judged by the investigator; per local regulations), or if sexually active, be practicing a highly effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel\], male partner sterilization) as local regulations permitted, before entry, and had to agree to continue to use the same method of contraception throughout the study
• A Positive and Negative Syndrome Scale (PANSS) total score at screening and at baseline (Day 1) of 60 to 120
• Documented history of exposure to either a risperidone formulation or a paliperidone formulation and known to be tolerated before baseline (Day 1) (Even if the participant's experience of taking risperidone or paliperidone cannot be confirmed at the time of informed consent, the participant will be able to meet this criterion if the participant takes oral risperidone 2 mg/day or more or paliperidone ER 6 mg/day or more for at least 4 days between the day of informed consent and the day before baseline, and it is possible to confirm that there is no lack of tolerability in the participant)
• Women of childbearing potential must have a negative beta human chorionic gonadotropin pregnancy test at the screening urine pregnancy test

You may not qualify if:

• Primary active Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision Axis I diagnosis other than schizophrenia
• Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
• History or current presence of neuroleptic malignant syndrome or tardive dyskinesia
• Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, Intralipid, or any of their excipients (including egg yolks, soybean oil, phospholipids, and glycerol)

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (56)

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Fujioka, Japan

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Fujisawa, Japan

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Fukui, Japan

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Fukuoka, Japan

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Hadano, Japan

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Ichikawa, Japan

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Itoman, Japan

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Kanzaki, Japan

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Kashihara, Japan

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Kasuya, Japan

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Kawasaki, Japan

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Kitagunma, Japan

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Kitakyushu, Japan

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Kobe, Japan

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Kodaira, Japan

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Koshigaya, Japan

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Kumagaya, Japan

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Kumamoto, Japan

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Kurayoshi, Japan

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Kure, Japan

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Kurume, Japan

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Mitaka, Japan

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Miyazaki, Japan

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Moriguchi, Japan

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Nanyō, Japan

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Nishinomiya, Japan

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Ohta, Japan

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Okinawa, Japan

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Oyabe, Japan

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Sakai, Japan

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Shibukawa, Japan

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Takatsuki, Japan

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Tamana, Japan

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Tokyo, Japan

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Toyama, Japan

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Toyoake, Japan

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Urasoe, Japan

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Yatsushiro, Japan

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Yokkaichi, Japan

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Yokohama, Japan

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Busan, South Korea

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Chungcheongbuk-Do, South Korea

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Daegu, South Korea

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Deajun, South Korea

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Incheon, South Korea

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Inchun, South Korea

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Jeonju, South Korea

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Seongnam, South Korea

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Seoul, South Korea

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Bali Township, Taipei County, Taiwan

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Changhua, Taiwan

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Hualien City, Taiwan

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Kaohsiung City, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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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

Results Point of Contact

• Title: Medical director
• Organization: Janssen Pharmaceutical K.K

+81-3-4411-5509

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: February 18, 2011
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 17, 2013
• Results First Posted: June 17, 2013

Record last verified: 2013-06

Locations

JP (40); KR (9); TW (7)