Phase 3
Completed N=1,429
Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01515423 ↗Enrolled (actual)
1,429
Serious AEs
6.7%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase — 91.5; 90.0 Percentage of Participants
◆ Published Evidence
Emerging
12citations · ~2 / year
Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation.
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.
Linked Publications (5)
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Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation.
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Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis.
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Improvement of Negative Symptoms in Schizophrenia with Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables: Results from a Phase 3 Non-Inferiority Study.
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Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies.
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Factors Associated with Symptom Stabilization that Allow for Successful Transition from Once-Monthly Paliperidone Palmitate to Three-Monthly Paliperidone Palmitate: A Post Hoc Analysis Examined Clinical Characteristics in Chinese Patients with Schizophrenia.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.