Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
DayBreak
Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
2 other identifiers
interventional
1,098
13 countries
142
Brief Summary
To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)
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 Apr 2016
Typical duration for phase_3 schizophrenia
142 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
First Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2018
CompletedResults Posted
Study results publicly available
November 25, 2019
CompletedNovember 25, 2019
October 1, 2019
2.4 years
March 11, 2016
August 30, 2019
October 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia.
From Randomization to Week 10
Secondary Outcomes (7)
Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score
From Randomization to Week 10
Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score
From Randomization to Week 10
Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4
From Randomization to Week 10
Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
From Randomization to Week 10
Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization
From Randomization to Week 10
- +2 more secondary outcomes
Study Arms (4)
Prospective Confirmation (PC) Period
EXPERIMENTALSingle (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
EXPERIMENTALEligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks
DBT Period, Lu AF35700 20 mg
EXPERIMENTALEligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks
DBT Period, Continued treatment from PC Period
EXPERIMENTALEligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period
Interventions
4-6 mg/day, encapsulated tablets, orally
15-20 mg/day, encapsulated tablets, orally
10 mg/day, encapsulated tablets, orally
Eligibility Criteria
You may qualify if:
- The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders
- The patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist.
- Patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to Screening
- The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to Screening. The failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s)
- The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the following PANSS items (at Screening and at the first visit of Period A)
- The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A
You may not qualify if:
- The patient has any current primary psychiatric disorder other than schizophrenia as assessed by the Mini International Neuropsychiatric Interview (MINI)
- The patient is experiencing an acute exacerbation of his/her psychotic symptoms
- The patient has not responded to treatment with clozapine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (147)
US1018
Bellflower, California, 90706, United States
US1041
Cerritos, California, 90703, United States
US1062
Costa Mesa, California, 92626, United States
US1463
Culver City, California, 90230, United States
US1104
Garden Grove, California, 92845, United States
US1118
Glendale, California, 91206, United States
US1114
National City, California, 91950, United States
US1452
Oceanside, California, 92056-4509, United States
US1459
Oceanside, California, 92056-4515, United States
US1399
Orange, California, 91945, United States
US1368
Orange, California, 92868, United States
US1391
San Bernardino, California, 92408-3332, United States
US1464
Santa Ana, California, 92705-3610, United States
US1384
Sherman Oaks, California, 91403-1747, United States
US1392
Torrance, California, 90502-4432, United States
US1396
Washington D.C., District of Columbia, 20016, United States
US1395
Bradenton, Florida, 32751, United States
US1253
Jacksonville, Florida, 32256, United States
US1130
Miami, Florida, 33122, United States
US1318
North Miami, Florida, 33161, United States
US1129
North Miami, Florida, 33162, United States
US1402
Oakland Park, Florida, 33334-4400, United States
US1229
Orange City, Florida, 32763, United States
US1453
Tampa, Florida, 33609-2231, United States
US1403
Atlanta, Georgia, 30328, United States
US1009
Atlanta, Georgia, 30331, United States
US1442
Decatur, Georgia, 30030, 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
US1454
Marlton, New Jersey, 08053, United States
US1405
Glen Oaks, New York, 11004, United States
US1244
Jamaica, 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, United States
US1390
Charlotte, North Carolina, 28204-3110, United States
US1401
Charlotte, North Carolina, 28211-1064, United States
US1441
Hickory, North Carolina, 28601-5045, United States
US1124
Norristown, Pennsylvania, 19403, United States
US1319
Charleston, South Carolina, 29407, United States
US1451
Austin, Texas, 78754-5122, United States
US1065
Dallas, Texas, 75243, United States
US1443
Fort Worth, Texas, 76104, United States
BG1030
Burgas, Bulgaria
BG1028
Kazanlak, Bulgaria
BG1003
Lovech, Bulgaria
BG1032
Pazardzhik, Bulgaria
BG1008
Plovdiv, Bulgaria
BG1024
Sofia, Bulgaria
BG1026
Sofia, Bulgaria
BG1022
Tserova Koria, Bulgaria
BG1033
Varna, Bulgaria
BG1034
Varna, Bulgaria
BG1029
Veliko Tarnovo, Bulgaria
BG1027
Vratsa, Bulgaria
CA1017
Chatham, Canada
CA1034
Kingston, Canada
CA1003
Montreal, Canada
CA1033
Montreal, Canada
CA1029
Penticton, Canada
CA1039
Québec, Canada
CZ1023
Brno, Czechia
CZ1032
Brno, Czechia
CZ1037
Hostivice, Czechia
CZ1013
Lnáře, Czechia
CZ1038
Prague, Czechia
EE1016
Pärnu, Estonia
EE1007
Tallinn, Estonia
EE1017
Viljandi, Estonia
FI1032
Espoo, Finland
FI1030
Kuopio, Finland
FI1027
Turku, Finland
MX1024
Durango, Mexico
MX1011
Guadalajara, Mexico
MX1021
Guadalajara, Mexico
MX1022
Guadalajara, Mexico
MX1020
México, Mexico
MX1005
Monterrey, Mexico
MX1007
Monterrey, Mexico
MX1015
Monterrey, Mexico
MX1016
Monterrey, Mexico
MX1018
San Luis Potosí City, Mexico
PL1025
Bełchatów, Poland
PL1043
Bialystok, Poland
PL1026
Gorlice, Poland
PL1060
Lodz, Poland
PL1027
Lublin, Poland
PL1058
Pruszcz Gdański, Poland
PL1061
Pruszków, Poland
PL1059
Torun, Poland
PL1051
Wroclaw, Poland
RO1024
Bucharest, Romania
RO1022
Campulung Muscel, Romania
RO1025
Sibiu, Romania
RO1004
Târgu Mureş, Romania
RU1021
Nikol’skoye, Gatchinckiy District, Russia
RU1009
Arkhangelsk, Russia
RU1006
Moscow, Russia
RU1051
Moscow, Russia
RU1055
Moscow, 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
RU1053
Saint Petersburg, Russia
RU1056
Saint Petersburg, Russia
RU1050
Yaroslavl, Russia
RS1008
Belgrade, Serbia
RS1010
Belgrade, Serbia
RS1012
Belgrade, Serbia
RS1011
Kragujevac, Serbia
RS1016
Kragujevac, Serbia
RS1017
Kragujevac, Serbia
RS1003
Niš, Serbia
RS1009
Novi Kneževac, Serbia
SK1014
Bratislava, Slovakia
SK1024
Bratislava, Slovakia
SK1015
Rožňava, Slovakia
SK1025
Svidník, Slovakia
SK1026
Zlaté Moravce, Slovakia
ES1047
Barcelona, Spain
ES1012
Madrid, Spain
ES1008
Málaga, Spain
ES1048
Oviedo, Spain
ES1049
Zamora, Spain
UA1019
Dnipropetrovsk, Ukraine
UA1017
Kharkiv, Ukraine
UA1022
Kharkiv, Ukraine
UA1031
Kharkiv, Ukraine
UA1035
Kharkiv, Ukraine
UA1028
Kherson, Ukraine
UA1029
Kherson, Ukraine
UA1027
Kiev, Ukraine
UA1030
Kiev, Ukraine
UA1033
Lviv, Ukraine
UA1020
Odesa, Ukraine
UA1032
Odesa, 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)
Intervention 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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2016
First Posted
March 23, 2016
Study Start
April 1, 2016
Primary Completion
August 30, 2018
Study Completion
October 8, 2018
Last Updated
November 25, 2019
Results First Posted
November 25, 2019
Record last verified: 2019-10