Phase 3
Completed N=838
A Study of Paliperidone Palmitate 6-Month Formulation
Source: ClinicalTrials.gov NCT03345342 ↗Enrolled (actual)
838
Serious AEs
4.1%
Results posted
Dec 2021
Primary outcomePrimary: Time to Relapse During the Double-Blind (DB) Phase — NA; NA Days
◆ Published Evidence
Established
62citations · ~16 / year
A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia.
Summary
The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).
Linked Publications (3)
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A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia.
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Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia.
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Efficacy and safety of paliperidone palmitate 6-monthly long-acting injectable in reduction of relapses in patients with schizophrenia: An Asian subgroup analysis of phase 3, randomized study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Relapse During the Double-Blind (DB) Phase |
NA; NA | — |
| SECONDARY Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score |
-1.6; -1.8 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score |
0.0; 0.0 | — |
| SECONDARY Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score |
1.1; 1.0 | — |
| SECONDARY Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase |
70.1; 66.3 | — |
| SECONDARY Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score |
0.9; 0.6 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score |
6.0; 3.6; 3.4; 1.1; 2.5; 0.5 | — |
| SECONDARY Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score |
0.00; 0.00 | — |
| SECONDARY Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score |
185; 380; 185; 380; 185; 380 | — |
| SECONDARY Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score |
0.0; 0.0 | — |
| SECONDARY Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score |
221; 477; 3; 0; 0; 1 | — |
| SECONDARY Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase |
5; 9; 20; 36; 3; 8 | — |
| SECONDARY Change From Baseline in the Body Mass Index (BMI) During DB Phase |
0.3; 0.0 | — |
| SECONDARY Change From Baseline in the Waist Circumference During DB Phase |
0.82; 0.37 | — |
| SECONDARY Change From Baseline in the Body Weight During DB Phase |
0.96; 0.10 | — |
| SECONDARY Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase |
1.2; 0.6; 2.6; 0.9; 1.5; 0.2 | — |
| SECONDARY Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase |
-0.3; 0.6; 0.8; 1.3; 1.0; 0.6 | — |
| SECONDARY Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase |
-0.1; -0.1; -0.6; -0.7; -0.9; -1.0 | — |
| SECONDARY Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase |
0; 0; 1; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening
- Must be receiving treatment with paliperidone palmitate (as either the paliperidone palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or injectable risperidone, or any oral antipsychotic
- Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M) or PP3M during the Screening Phase
- Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (<) 70 points at screening
- Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)^2 (inclusive) and must have a body weight of at least 47 kg at screening
- Must be willing to receive gluteal injections of medication during the Double-blind Phase
Exclusion Criteria
- Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment
- Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening
- Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator
- Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia
- Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe
Data sourced from ClinicalTrials.gov (NCT03345342) 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.