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

NCT02901587 Phase 1 COMPLETED

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

Details

Lead sponsor	H. Lundbeck A/S
Phase	Phase 1
Status	COMPLETED
Enrolment	119
Start date	2016-09
Completion	2018-04-18

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

• Lu AF35700 (10 mg/day)
• Lu AF35700 (30 mg/day)
• Quetiapine (Seroquel XR® 800 mg/day)

Primary outcomes

• Change from time-matched baseline on day 1, 21, and 42 in QTcF — Before dose to 10 hours post dose

Countries

United States