Phase 4
N=75
An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00992407 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52 — 50.65; 58.71; 5.35; 5.96 units on a scale — p=0.8595
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Risperidone long acting injectables (Drug); Risperidone tablets (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Korea, Ltd., Korea
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52 |
50.65; 58.71; 5.35; 5.96 | 0.8595 |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52 |
78.0; 69.5; -11.7; -13.0 | 0.8118 |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52 |
3.4; 2.8; -0.6; -0.7 | — |
| SECONDARY Change From Baseline in Social Functioning Scale (SFS) Score at Week 52 |
99.6; 103.5; 2.3; 9.6 | — |
| SECONDARY Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 |
178.7; 173.7; 151.4; 152.9; 84.1; 87.1 | — |
| SECONDARY Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 |
7.5; 9.3; 11.6; 11.8; 2.0; 1.0 | — |
| SECONDARY Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 |
52.6; 50.7; 146.0; 147.3; 5.9; -7.8 | — |
| SECONDARY Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 |
11.6; 14.3; 10.5; 14.9; 1.0; 0.5 | — |
| SECONDARY Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 |
11.0; 14.2; 17.4; 29.3; 1.6; -12.2 | — |
| SECONDARY Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 |
13.8; 18.5; 6.0; 6.6; 14.2; 15.5 | — |
| SECONDARY Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52 |
93.8; 96.0; 10.7; 0.7 | 0.1768 |
| SECONDARY Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52 |
58.3; 63.4; 5.4; 5.7 | 0.9569 |
| SECONDARY Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52 |
12.1; 10.6; -4.8; -3.5 | 0.5294 |
| SECONDARY Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Score at Week 52 |
4.1; 5.0; -4.7; -1.1 | — |
| SECONDARY Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 |
0.8; 0.7; 2.2; 2.9; 0.6; 0.7 | — |
| SECONDARY Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 |
19.4; 9.8; 34.0; 24.3; 2.9; 2.0 | — |
| SECONDARY Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 |
1.7; 1.6; 1.4; 1.4; 0.1; -0.2 | — |
| SECONDARY Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 |
4645.8; 4850.0; 3500.0; 9500.0; 0.0; 3000.0 | — |
| SECONDARY Change From Baseline in Number of Outpatient Clinic Visits at Week 52 |
4.7; 4.4; 2.4; 1.1 | — |
| SECONDARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52 |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52 |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 |
0.80; 0.40; 0.40; 0.32; -0.16; 0.00 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder).
Eligibility Criteria
Inclusion Criteria: - Participants who will understand the objectives and necessary procedures of the study and have signed the informed consent form which specified that they were willing to participate in the study - Participants with schizophrenia or schizoaffective disorder requiring long-term antipsychotic drug therapy - Participants with pre-morbid global assessment of functioning score of 71 or higher at Screening - Participants who do not present clinically significant abnormality in biochemistry and electrocardiography - Participants who will be compliant with the study requirements (that is, filling in the questionnaire by themselves) and who are capable of actually performing and willing to implementing them
Exclusion Criteria: - Participants who had taken clozapine for the past three months - Participants with mental retardation (Intelligence Quotient less than 70 at the screening) - Participants with history of or currently with a serious disease (cardiovascular, respiratory, neurological [including seizures or significant cerebrovascular], renal, hepatic, hematologic, endocrine, immunologic or other systemic disease) including clinically relevant abnormal level - Participants who have an allergic or hypersensitive reaction to risperidone or who are unresponsive to risperidone - Pregnant or lactating female participants
Data sourced from ClinicalTrials.gov (NCT00992407). 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.