Schizophrenia
Conditions
Brief summary
The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.
Interventions
DRUGaripiprazole
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
DRUGPlacebo
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
Sponsors
Otsuka America Pharmaceutical
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.
Exclusion criteria
* Patients known to be allergic to aripiprazole * Hospitalized patients * Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine. | — |
| The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (PANSS, CGI) | — |
| Effectiveness (IAQ, GAF) | — |
| Patient Reported Outcomes | — |
| Safety | — |
Countries
Austria, Czechia, Finland, France, Germany, Hungary, Poland, South Africa, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Outcome results
None listed