At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,098 enrolled
Drug / intervention
Risperidone +3 moredrug
Likely dose
Risperidone 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Risperidone, Olanzapine, and 1 other intervention for Schizophrenia. Completed, enrolled 1,098 participants across 147 sites in 14 countries.
Detailed Summary
To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Canada, Czechia, Estonia, Finland, Mexico, Poland, Romania, Russia, Serbia, Slovakia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionAug 2018
Study CompletionOct 2018
TodayJul 2026
First PostedMar 23, 2016
Enrollment StartApr 1, 2016
Primary CompletionAug 30, 2018
Study CompletionOct 8, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.3 years ago
Interventions
Risperidonedrug
4-6 mg/day, encapsulated tablets, orally
Olanzapinedrug
15-20 mg/day, encapsulated tablets, orally
Lu AF35700drug
10 mg/day, encapsulated tablets, orally
Lu AF35700drug
20 mg/day, encapsulated tablets, orally