Antipsychotics, Aripiprazole, LAI, Long-Acting Injection, Schizophrenia
Conditions
Keywords
aripiprazole, Long-Acting Injection
Brief summary
Interventional, multicenter, open-label, 20 weeks study * To identify efficacy and safety in switching from oral aripiprazole to Abilify Maintena. * To identify efficacy and safety in switching from oral atypical antipsychotics other than aripiprazole to Abilify Maintena
Detailed description
We would like to evaluate the efficacy and safety when switching to Abilify Maintena according to the approved indication of Abilify Maintena, for subjects who are taking oral antipsychotic drugs. It is expected that this will serve as a basis for suggesting a successful switching guideline from oral antipsychotics to Abilify Maintena, which can be applicable in clinical practice.
Interventions
DRUGAbilify maintena
Switching from oral atypical antipsychotics to long-acting injectable aripiprazole (Abilify maintena)
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who voluntarily consented to participating in the clinical trial. 2. Male and female legally aged ≥19 and \< 65 years. 3. Subjects who were diagnosed of schizophrenia as defined by DSM diagnostic criteria, and were diagnosed of schizophrenia for at least for 2 years prior to screening. 4. Subjects with all of the following schizophrenia clinical features: A. Outpatient subjects, with no hospitalization for worsening of schizophrenia within 3 months prior to screening. B. Subjects who have no more than a moderate rating on the PANSS total score≤80 C. 4 individual PANSS items, which are concerning to psychotic symptom (P2. conceptual disorganization, P3. hallucinatory behavior, P6. suspiciousness/persecution, G9. unusual thought content), score≤4. D. CGI-S score ≤4 (moderately ill). 5. Subjects who take atypical antipsychotic drugs with the therapeutic effective dose (as specified in each label) for schizophrenia treatment, and should be maintained on the type and dose of the current antipsychotic drugs (including both typical and atypical antipsychotic drugs) for at least 4 weeks prior to the screening. 6. Subjects who need antipsychotic treatment (other than clozapine), and would be stable when switching to Abilify Maintena on the investigator's judgement. 7. Subjects must exhibit willingness, physiologic capability, and an educational level sufficient to comply with all protocol procedures as per the investigator's judgment.
Exclusion criteria
1. Subject who showed medically significant adverse events or intolerance with aripiprazole during screening period or as prior experiences. 2. Subjects with a current DSM diagnostic criteria-based diagnosis other than schizophrenia, including Schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, neurocognitive disorder due to Alzheimer's or similar diseases, amnesia, borderline, paranoid, histrionic, schizotypal, schizoid, antisocial or other cognitive or personality disorders. 3. Subjects with diseases of the central nervous system that may impact the assessment of the psychotic symptoms as per investigator's opinion. 4. Subjects who have been treated with clozapine, electroconvulsive therapy (ECT) or other long-acting injectable antipsychotic drugs within 3 months prior to the screening. 5. Subjects who have been treated more than 2 oral antipsychotic drugs (including both typical and atypical antipsychotic drugs) with the minimum therapeutic effective dose (as specified in each label) for schizophrenia treatment at screening. (e.g. Aripiprazole≥10 mg/day, Olanzapine≥10 mg/day, Risperidone≥2 mg/day, Quetiapine ≥150 mg/day) 6. Subjects who have been treated with oral antipsychotic drugs (including both typical and atypical antipsychotic drugs) exceeding maximum maintenance dose (as specified in each label) at screening. (e.g. Aripiprazole\>30 mg/day, Olanzapine\>20 mg/day, Risperidone \> 6 mg/day, Quetiapine \> 750 mg/day) 7. Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment. 8. Subjects had a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose them to undue risk or interfere with study assessments. 9. Significant history of drug abuse disorder (excluding caffeine and nicotine, including alcohol, as defined in DSM-5 substance use disorder or in the opinion of the investigator) within the last 6 months prior to screening. 10. Subjects who participated in another interventional clinical trial within 30 days prior to screening. 11. Pregnant or lactating women, or women of childbearing potential who are not willing to or not able to use contraceptive methods (sexual abstinence; oral, implanted or injection hormone contraceptive methods; intrauterine device or condom; barrier contraceptive methods such as diaphragm and spermicide), accepted to avoid pregnancy until the end of the clinical trial. 12. Subjects having any other clinically significant finding of the physical examination or laboratory value that make investigator consider that it would be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PANSS total score | 16 weeks | Change in PANSS total score from baseline to Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGI-S | 16 weeks | Change in CGI-S (severity) from baseline to Week 16 |
| CGI-I | 16 weeks | Mean CGI-I (improvement) score at Week 16 |
| PANSS positive and negative subscale score | 16 weeks | Change in PANSS positive and negative subscale score from baseline to Week 16 |
| IAQ score | 16 weeks | Mean IAQ score at Week 16 |
Other
| Measure | Time frame | Description |
|---|---|---|
| study discontinuation rates | 16 weeks | Comparison the study discontinuation rates between Group 1 and Group 2 |
| proportion of subjects who have more than 20% increased rating on the PANSS total score | 16 weeks | Comparison the proportion of subjects who have more than 20% increased rating on the PANSS total score from baseline to Week 16 between Group 1and Group 2 |
Countries
South Korea
Outcome results
None listed