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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901587
• Other study ID #: 16323A
• Status: Completed
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: April 18, 2018

Study information

• Verified date: September 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• The patient is able by her/himself to provide informed consent to participate in the study

• The patient has a primary diagnosis of schizophrenia or schizoaffective disorder (DSM-5™ criteria)

• The patient has BMI =35 kg/m2

• The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score =4 (moderately ill)

• PANSS total score = 80 and a score =4 (moderate) on the PANSS items, P7 (hostility) and G8 (uncooperativeness)

• The patient is willing to be hospitalized for up to 8 weeks

• The patient is generally healthy based on medical history, physical examination, vital signs, ECG, and laboratory tests.

• The patient agrees to protocol-defined use of effective contraception

Exclusion Criteria:´

• The patient experienced acute exacerbation of psychosis requiring hospitalization within the last 3 months or required change in medication due to exacerbation of psychosis within the last 8 weeks

• The patient has met moderate or severe co-morbid Substance Abuse Disorder DSM-5™ criteria in the last 3 months

• The patient is at significant risk of harming her/himself or others in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS)

• The patient has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)

Other protocol defined inclusion and exclusion criteria may apply

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Lu AF35700 (10 mg/day)
tablets for oral administration once daily
• Lu AF35700 (30 mg/day)
tablets for oral administration once daily
• Quetiapine (Seroquel XR® 800 mg/day)
tablets for oral administration once daily

Locations

Country	Name	City	State
United States	US1104	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from time-matched baseline on day 1, 21, and 42 in QTcF		Before dose to 10 hours post dose