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

September 11, 2019 updated by: H. Lundbeck A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States
        • US1104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lu AF35700 (10 mg/day)
Lu AF35700 10 mg/day for 6 weeks
Drug: Lu AF35700 (10 mg/day)
tablets for oral administration once daily
EXPERIMENTAL: Lu AF35700 (30 mg/day)
Lu AF35700 30 mg/day for 6 weeks
Drug: Lu AF35700 (30 mg/day)
tablets for oral administration once daily
EXPERIMENTAL: Quetiapine (Seroquel XR® 800 mg/day)
Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks
Drug: Quetiapine (Seroquel XR® 800 mg/day)
tablets for oral administration once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from time-matched baseline on day 1, 21, and 42 in QTcF
Time Frame: Before dose to 10 hours post dose
Before dose to 10 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

April 18, 2018

Study Completion (ACTUAL)

April 18, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (ESTIMATE)

September 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16323A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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