Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
NCT02901587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 119
Last updated 2019-09-12
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
- 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
Sponsors & Collaborators
-
H. Lundbeck A/S
lead INDUSTRY
Principal Investigators
-
Email contact via H. Lundbeck A/S · [email protected]
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2018-04-18
- Completion
- 2018-04-18
Countries
- United States
Study Locations
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