Phase 3
N=667
A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01193153 ↗Enrolled (actual)
667
Serious AEs
7.9%
Results posted
Jan 2015
Primary outcome: Primary: Double-blind: Percentage of Participants Who Experienced Relapse — 15.2; 33.5; 11.5; 32.9 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); paliperidone palmitate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Scientific Affairs, LLC
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-blind: Percentage of Participants Who Experienced Relapse |
15.2; 33.5; 11.5; 32.9; 18.6; 34.0 | <0.001 sig |
| SECONDARY Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA]) |
72.8; 74.5; 2.0; -1.3 | 0.014 sig |
| SECONDARY Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint |
51.4; 12.6; 13.8 | — |
| SECONDARY Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint |
74.5; 72.8; 0.5; -4.1 | <0.001 sig |
| SECONDARY Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores |
0; 0; 69; 84; 95; 86 | — |
| SECONDARY Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint |
85.8; -21.8; -23.8 | — |
| SECONDARY Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint |
51.1; 51.8; 0.5; 7.4 | — |
| SECONDARY Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint |
20.4; -9.7; -9.9 | — |
| SECONDARY Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint |
5.7; 5.6; 0.8; 3.4 | — |
| SECONDARY Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint |
18.6; -9.9; -10.5 | — |
| SECONDARY Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint |
4.4; 4.4; -0.1; 3.2 | — |
| SECONDARY Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint |
4.4; -1.3; -1.3 | — |
| SECONDARY Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint |
2.4; 2.5; 0.0; 0.4 | — |
Summary
This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
Eligibility Criteria
Inclusion Criteria
- DSM-IV diagnosis of schizoaffective disorder
- Experiencing an acute exacerbation of psychotic symptoms
- A score of >=4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14)
- A score of >=16 on YMRS and/or a score of >=16 on the HAM-D-21
- Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
Exclusion Criteria
- A primary active mental illness diagnosis other than schizoaffective disorder
- Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior
- Subjects with first episode of psychosis
- Received electroconvulsive therapy in the past 3 months
- History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)
- Received long-acting antipsychotic medication within 2 injection cycles
- Received therapy with clozapine within 3 months
- A history of neuroleptic malignant syndrome
- Previous history of lack of response to antipsychotic medication
- Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening
- Receiving therapy with carbamazepine
- Receiving therapy with monoamine oxidase inhibitors
- Pregnant, breast-feeding, or planning to become pregnant
Data sourced from ClinicalTrials.gov (NCT01193153). 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.