NCT02901587

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started Sep 2016

Typical duration for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

September 12, 2016

Last Update Submit

September 11, 2019

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

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

    Before dose to 10 hours post dose

Study Arms (3)

Lu AF35700 (10 mg/day)

EXPERIMENTAL

Lu AF35700 10 mg/day for 6 weeks

Drug: Lu AF35700 (10 mg/day)

Lu AF35700 (30 mg/day)

EXPERIMENTAL

Lu AF35700 30 mg/day for 6 weeks

Drug: Lu AF35700 (30 mg/day)

Quetiapine (Seroquel XR® 800 mg/day)

EXPERIMENTAL

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

Drug: Quetiapine (Seroquel XR® 800 mg/day)

Interventions

Lu AF35700 (10 mg/day)DRUG

tablets for oral administration once daily

Lu AF35700 (10 mg/day)
Lu AF35700 (30 mg/day)DRUG

tablets for oral administration once daily

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

tablets for oral administration once daily

Quetiapine (Seroquel XR® 800 mg/day)

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US1104

Long Beach, California, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Lu AF35700Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

April 18, 2018

Study Completion

April 18, 2018

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)