A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia

NCT01541371 | Completed Phase 3 Results

• 2 other identifiers: CR016165R076477-SCH-3035
• Study Type: interventional
• Target: 405
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in 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) who were not satisfied with other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine, quetiapine and risperidone) they had been taking. The safety and tolerability of paliperidone ER tablets will also be assessed.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone extended-release tablets

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12

  PANSS is a medical scale that assesses various symptoms of 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). The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).

  Baseline and Week 12

Secondary Outcomes (7)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12

  Baseline and Week 12

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12

  Baseline and Week 12

• Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score

  Week 12

• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12

  Baseline and Week 12

• Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12

  Baseline and Week 12

Study Arms (1)

Paliperidone ER

EXPERIMENTAL

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

Paliperidone Extended Release (ER) 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks.

Paliperidone ER

Eligibility Criteria

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

You may qualify if:

• Participants meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis criteria of schizophrenia
• Participant receiving full course of treatment (6-8 weeks) at correct dose (dose range recommended by the instruction) of Risperdal, Zyprexa or Seroquel before enrollment, was poorly controlled and had to change medication because of unsatisfying efficacy, tolerability or safety issues, or other reason
• Participant in the non-acute phase during screening received treatment with any of above three antipsychotics within 4 weeks before enrollment and state of illness was relatively stable
• \. Female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study. Effective methods of birth control include prescription hormonal contraceptives, contraceptive injections, intrauterine devices, double barrier method, contraceptive patch and male partner sterilization. Female participants must also have a negative urine pregnancy test at screening
• Participant willing to and who could complete questionnaire by himself

You may not qualify if:

• Participant receiving treatment with clozapine or risperidone microspheres for injection (Hengde) within 3 months before screening
• Participant having history of seizure except febrile convulsion (seizures that occur during a febrile episode \[fever\])
• Participant having refractory schizophrenia (previous treatment with unsatisfied efficacy of 2 or more than 2 kinds of antipsychotics with different chemical structure after adequate dose and duration)
• Participant receiving electric shock treatment within 1 month before screening
• Participant having serious, unstable physical diseases

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

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: Therapeutic Area Manager
• Organization: CDMA, Beijing

00861058218352

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: July 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 7, 2013
• Results First Posted: August 7, 2013

Record last verified: 2013-07