NCT02901587

Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder

Interventional, Randomised, Double-blind, Parallel-group, Active-control, Multiple-dose Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Lu AF35700 (10 mg/day)	tablets for oral administration once daily
DRUG	Lu AF35700 (30 mg/day)	tablets for oral administration once daily
DRUG	Quetiapine (Seroquel XR® 800 mg/day)	tablets for oral administration once daily

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-04-18
• Completion: 2018-04-18
• First posted: 2016-09-15
• Last updated: 2019-09-12

Locations

1 site across 1 country: United States