NCT02717195

Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,098 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

Detailed description

The study consists of a Screening Period (3 weeks), a single-blind Prospective Confirmation (PC) Period (6 weeks), a Double-blind Treatment (DBT) Period (10 weeks), and a Safety Follow-up Period (6 weeks). Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period. Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period and were randomized into one of 3 treatment arms (1:1:1) with either Lu AF35700 10 mg/day, Lu AF35700 20 mg/day or to continue the treatment allocated in PC Period (olanzapine or risperidone) at the dose set at last visit of PC Period. This mean that approximately one third of the confirmed treatment-resistant patients were randomised back to the failed treatment used in the PC Period. Data was not collected separately for the DBT Olanzapine and DBT Risperidone participants, and there was no intent to compare Lu AF35700 to each drug separately.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Risperidone	4-6 mg/day, encapsulated tablets, orally
DRUG	Olanzapine	15-20 mg/day, encapsulated tablets, orally
DRUG	Lu AF35700	10 mg/day, encapsulated tablets, orally
DRUG	Lu AF35700	20 mg/day, encapsulated tablets, orally

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-08-30
• Completion: 2018-10-08
• First posted: 2016-03-23
• Last updated: 2019-11-25
• Results posted: 2019-11-25

Locations

147 sites across 14 countries: United States, Bulgaria, Canada, Czechia, Estonia, Finland, Mexico, Poland, Romania, Russia, Serbia, Slovakia, Spain, Ukraine