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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lu AF35700 (10 mg/day)

Lu AF35700 (30 mg/day)

Quetiapine (Seroquel XR® 800 mg/day)

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

US1104

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Lu AF35700 (10 mg/day)

Lu AF35700 (30 mg/day)

Quetiapine (Seroquel XR® 800 mg/day)

Arm Description

Lu AF35700 10 mg/day for 6 weeks

Lu AF35700 30 mg/day for 6 weeks

Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks

Outcomes

Primary Outcome Measures

Change from time-matched baseline on day 1, 21, and 42 in QTcF

Secondary Outcome Measures

Full Information

NCT ID

NCT02901587

First Posted

September 12, 2016

Last Updated

September 11, 2019

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT02901587

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

April 18, 2018 (Actual)

Study Completion Date

April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lu AF35700 (10 mg/day)

Arm Type

Experimental

Arm Description

Lu AF35700 10 mg/day for 6 weeks

Arm Title

Lu AF35700 (30 mg/day)

Arm Type

Experimental

Arm Description

Lu AF35700 30 mg/day for 6 weeks

Arm Title

Quetiapine (Seroquel XR® 800 mg/day)

Arm Type

Experimental

Arm Description

Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Lu AF35700 (10 mg/day)

Intervention Description

tablets for oral administration once daily

Intervention Type

Drug

Intervention Name(s)

Lu AF35700 (30 mg/day)

Intervention Description

tablets for oral administration once daily

Intervention Type

Drug

Intervention Name(s)

Quetiapine (Seroquel XR® 800 mg/day)

Intervention Description

tablets for oral administration once daily

Primary Outcome Measure Information:

Title

Change from time-matched baseline on day 1, 21, and 42 in QTcF

Time Frame

Before dose to 10 hours post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Email contact via H. Lundbeck A/S

Organizational Affiliation

LundbeckClinicalTrials@Lundbeck.com

Official's Role

Study Director

Facility Information:

Facility Name

US1104

City

Long Beach

State/Province

California

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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