Phase 3
N=506
A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01529515 ↗Enrolled (actual)
506
Serious AEs
6.4%
Results posted
Jun 2015
Primary outcome: Primary: Time to Relapse During the Double-Blind Phase — 395.0; NA Days
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 emulsion) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Relapse During the Double-Blind Phase |
395.0; NA | — |
| SECONDARY Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase |
54.3; 54.8; 6.7; -0.5 | — |
| SECONDARY Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase |
2.8; 2.7; 0.4; 0.1 | — |
| SECONDARY Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase |
68.5; 68.9; -4.2; -0.5 | — |
Summary
The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.
Eligibility Criteria
Inclusion Criteria
- Patients with schizophrenia for more than 1 year
- A total score in the Positive and Negative Syndrome Scale (PANSS) < 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 (NCT01529515). 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.