Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
Debut
Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
2 other identifiers
interventional
528
12 countries
101
Brief Summary
To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Aug 2016
Typical duration for phase_3 schizophrenia
101 active sites
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
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 29, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2019
CompletedResults Posted
Study results publicly available
October 26, 2020
CompletedOctober 26, 2020
September 1, 2020
3.2 years
August 29, 2016
September 30, 2020
September 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG)
From dosing to end of study (57 weeks)
Study Arms (1)
Flexible-dose of Lu AF35700
EXPERIMENTALInterventions
Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
Eligibility Criteria
You may qualify if:
- \- For 16159A-patients
- The patient has completed Study 16159A.
- The patient is able to read and understand the Informed Consent Form.
- The patient has signed the Informed Consent Form specific for Study 16159B.
- The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
- For 16323A-patients
- The patient has completed the dosing period of Study 16323A.
- The patient is able to read and understand the Informed Consent Form.
- The patient has signed the Informed Consent Form specific Study 16159B.
- The patient has a confirmed diagnosis of schizophrenia according to DSM-5™.
- The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
- For Other Patients
- The patient has schizophrenia, diagnosed according to DSM-5™.
- The patient is a man or woman, aged ≥18 years.
- The patient has been prescribed oral antipsychotic treatment at the recommended dose range as stated in the summary of product characteristics or equivalent label for 6 weeks prior to the Screening Visit.
- +6 more criteria
You may not qualify if:
- \- For 16159A-patients
- The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16159A.
- The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the Columbia-Suicide Severity Rating Scale (C-SSRS), OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
- For 16323A-patients
- The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16323A.
- The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
- For Other Patients
- The patient has any current psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis.
- The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
- The patient is treated with clozapine at the time of the Screening Visit.
- The patient has a substance use disorder (except nicotine) which according to the investigator's judgment may compromise the patient's ability to comply with the study procedures, or preclude the benefits of the study medication.
- The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (102)
US1018
Bellflower, California, United States
US1062
Costa Mesa, California, 92626, United States
US1463
Culver City, California, United States
US1399
Escondido, California, 91945, United States
US1104
Garden Grove, California, 92845, United States
US1114
National City, California, 91950, United States
US1459
Oceanside, California, United States
US1368
Orange, California, 92868, United States
US1391
San Bernardino, California, 92408-3332, United States
US1392
Torrance, California, 90502-4432, United States
US1318
Lauderhill, Florida, 33319, United States
US1130
Miami, Florida, 33122, United States
US1129
North Miami, Florida, 33161-5834, United States
US1402
Oakland Park, Florida, 33334-4400, United States
US1403
Atlanta, Georgia, 30328, United States
US1009
Atlanta, Georgia, 30331, United States
US1046
Chicago, Illinois, 60640, United States
US1423
Hoffman Estates, Illinois, 60169-1067, United States
US1398
Shreveport, Louisiana, 71101-4603, United States
US1404
Shreveport, Louisiana, 71104-2136, United States
US1086
Flowood, Mississippi, 39232, United States
US1444
Las Vegas, Nevada, 89102-1943, United States
US1426
Berlin, New Jersey, 08009, United States
US1244
Fresh Meadows, New York, 11432, United States
US1394
New York, New York, 10032, United States
US1416
New York, New York, 10035-6000, United States
US1171
Rochester, New York, 14618, United States
US1190
Staten Island, New York, 10312-6501, United States
US1390
Charlotte, North Carolina, 28204-3110, United States
US1124
Norristown, Pennsylvania, 19403, United States
US1451
Austin, Texas, 78754-5122, United States
US1065
Dallas, Texas, 75243, United States
BG1030
Burgas, Bulgaria
BG1028
Kazanlak, Bulgaria
BG1003
Lovech, Bulgaria
BG1008
Plovdiv, Bulgaria
BG1024
Sofia, Bulgaria
BG1026
Sofia, Bulgaria
BG1034
Varna, Bulgaria
BG1029
Veliko Tarnovo, Bulgaria
BG1027
Vratsa, Bulgaria
CA1029
Penticton, Canada
CZ1023
Brno, Czechia
CZ1032
Brno, Czechia
CZ1013
Lnáře, Czechia
CZ1038
Prague, Czechia
EE1007
Tallinn, Estonia
MX1024
Durango, Mexico
MX1011
Guadalajara, Mexico
MX1021
Guadalajara, Mexico
MX1022
Guadalajara, Mexico
MX1020
Mexico City, Mexico
MX1005
Monterrey, Mexico
MX1007
Monterrey, Mexico
MX1015
Monterrey, Mexico
PL1043
Bialystok, Poland
PL1060
Lodz, Poland
PL1058
Pruszcz Gdański, Poland
PL1059
Torun, Poland
PL1051
Wroclaw, Poland
RO1024
Bucharest, Romania
RU1009
Arkhangelsk, Russia
RU1021
Gatchina, Russia
RU1006
Moscow, Russia
RU1051
Moscow, Russia
RU1055
Moscow, Russia
RU1053
Roshchino, Russia
RU1023
Saint Petersburg, Russia
RU1028
Saint Petersburg, Russia
RU1030
Saint Petersburg, Russia
RU1031
Saint Petersburg, Russia
RU1049
Saint Petersburg, Russia
RU1052
Saint Petersburg, Russia
RU1056
Saint Petersburg, Russia
RU1050
Yaroslavl, Russia
RS1008
Belgrade, Serbia
RS1010
Belgrade, Serbia
RS1012
Belgrade, Serbia
RS1001
Kovin, Serbia
RS1011
Kragujevac, Serbia
RS1016
Kragujevac, Serbia
RS1017
Kragujevac, Serbia
RS1009
Novi Kneževac, Serbia
SK1014
Bratislava, Slovakia
SK1024
Bratislava, Slovakia
SK1026
Zlaté Moravce, Slovakia
ES1047
Barcelona, Spain
ES1008
Málaga, Spain
ES1048
Oviedo, Spain
UA1017
Kharkiv, Ukraine
UA1035
Kharkiv, Ukraine
UA1029
Kherson, Ukraine
UA1027
Kiev, Ukraine
UA1028
Kiev, Ukraine
UA1030
Kiev, Ukraine
UA1031
Kiev, Ukraine
UA1033
Lviv, Ukraine
UA1019
Odesa, Ukraine
UA1020
Odesa, Ukraine
UA1032
Oleksandrivka, Ukraine
UA1001
Poltava, Ukraine
UA1036
Vinnitsa, Ukraine
Related Publications (1)
Kane JM, Kinon BJ, Forray C, Such P, Mittoux A, Lemming OM, Hertel P, Howes OD; DayBreak and Debut study investigators. Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension. Schizophr Res. 2022 Oct;248:271-278. doi: 10.1016/j.schres.2022.09.012. Epub 2022 Sep 14.
PMID: 36115192DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Email contact via
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2016
First Posted
September 8, 2016
Study Start
August 1, 2016
Primary Completion
October 10, 2019
Study Completion
October 10, 2019
Last Updated
October 26, 2020
Results First Posted
October 26, 2020
Record last verified: 2020-09