Phase 3
N=1,429
Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01515423 ↗Enrolled (actual)
1,429
Serious AEs
6.7%
Results posted
May 2016
Primary outcome: Primary: Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase — 91.5; 90.0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PP3M 175 mg eq. (Drug); PP3M 263 mg eq. (Drug); PP3M 350 mg eq. (Drug); PP3M 525 mg eq. (Drug); Placebo (20% Intralipid) (Drug); PP1M 50 mg eq. (Drug); PP1M 75 mg eq. (Drug); PP1M 100 mg eq. (Drug); PP1M 150 mg eq. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase |
91.5; 90.0 | — |
| SECONDARY Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 |
57.4; 58.1; -3.5; -4.3 | — |
| SECONDARY Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 |
2.9; 2.9; -0.1; -0.1 | — |
| SECONDARY Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 |
65.5; 65.0; 1.3; 1.9 | — |
| SECONDARY Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria |
58.4; 59.2 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 |
11.9; 12.0; -0.6; -0.9; 17.3; 17.3 | — |
| SECONDARY Change From Baseline in Marder Factor Subscale Score at Week 48 |
15.7; 15.8; -1.1; -1.4; 16.2; 16.3 | — |
Summary
The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.
Eligibility Criteria
Inclusion Criteria
- Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator
- A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120
- Signed informed consent
- Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
- Men must agree to use a double-barrier method of birth control
- Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG)
Exclusion Criteria
- A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
- Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
- A diagnosis of substance dependence within 6 months before screening
- History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
- Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
- Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
- Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
Data sourced from ClinicalTrials.gov (NCT01515423). 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.