Phase 3
N=403
A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01541371 ↗Enrolled (actual)
403
Serious AEs
0.3%
Results posted
Aug 2013
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 — 77.18; 58.46; 63.33; -26.29 unit on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paliperidone ER (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 |
77.18; 58.46; 63.33; -26.29; -13.99; -20.90 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12 |
17.07; -6.59; 18.57; -6.14; 34.44; -10.84 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 |
21.61; -8.16; 19.15; -6.53; 14.13; -4.13 | — |
| SECONDARY Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score |
65.97; 51.72; 61.90 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12 |
4.54; 3.20; 3.86; -1.77; -1.01; -1.66 | — |
| SECONDARY Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12 |
53.16; 66.95; 66.00; 18.57; 10.09; 12.40 | — |
| SECONDARY Number of Participants With Satisfaction With the Study Treatment |
1; 3; 0; 15; 30; 15 | — |
| SECONDARY Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12 |
60.76; 75.89; 70.31; 15.76; 2.90; 13.60 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 7. 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01541371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.