Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
NCT ID: NCT02717195
Last Updated: 2019-11-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1098 participants
INTERVENTIONAL
2016-04-30
2018-10-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
NCT03230864
Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
NCT02892422
Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms
NCT03929497
Efficacy of Lu 31-130 in Patients With Schizophrenia
NCT00770744
Lurasidone Low-Dose - High-Dose Study Study
NCT01821378
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period.
Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period and were randomized into one of 3 treatment arms (1:1:1) with either Lu AF35700 10 mg/day, Lu AF35700 20 mg/day or to continue the treatment allocated in PC Period (olanzapine or risperidone) at the dose set at last visit of PC Period. This mean that approximately one third of the confirmed treatment-resistant patients were randomised back to the failed treatment used in the PC Period.
Data was not collected separately for the DBT Olanzapine and DBT Risperidone participants, and there was no intent to compare Lu AF35700 to each drug separately.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prospective Confirmation (PC) Period
Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Risperidone
4-6 mg/day, encapsulated tablets, orally
Olanzapine
15-20 mg/day, encapsulated tablets, orally
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
Eligible 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
Lu AF35700
10 mg/day, encapsulated tablets, orally
DBT Period, Lu AF35700 20 mg
Eligible 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
Lu AF35700
20 mg/day, encapsulated tablets, orally
DBT Period, Continued treatment from PC Period
Eligible 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
Risperidone
4-6 mg/day, encapsulated tablets, orally
Olanzapine
15-20 mg/day, encapsulated tablets, orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Risperidone
4-6 mg/day, encapsulated tablets, orally
Olanzapine
15-20 mg/day, encapsulated tablets, orally
Lu AF35700
10 mg/day, encapsulated tablets, orally
Lu AF35700
20 mg/day, encapsulated tablets, orally
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* The patient is experiencing an acute exacerbation of his/her psychotic symptoms
* The patient has not responded to treatment with clozapine
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
H. Lundbeck A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
US1018
Bellflower, California, United States
US1041
Cerritos, California, United States
US1062
Costa Mesa, California, United States
US1463
Culver City, California, United States
US1104
Garden Grove, California, United States
US1118
Glendale, California, United States
US1114
National City, California, United States
US1452
Oceanside, California, United States
US1459
Oceanside, California, United States
US1399
Orange, California, United States
US1368
Orange, California, United States
US1391
San Bernardino, California, United States
US1464
Santa Ana, California, United States
US1384
Sherman Oaks, California, United States
US1392
Torrance, California, United States
US1396
Washington D.C., District of Columbia, United States
US1395
Bradenton, Florida, United States
US1253
Jacksonville, Florida, United States
US1130
Miami, Florida, United States
US1318
North Miami, Florida, United States
US1129
North Miami, Florida, United States
US1402
Oakland Park, Florida, United States
US1229
Orange City, Florida, United States
US1453
Tampa, Florida, United States
US1403
Atlanta, Georgia, United States
US1009
Atlanta, Georgia, United States
US1442
Decatur, Georgia, United States
US1046
Chicago, Illinois, United States
US1423
Hoffman Estates, Illinois, United States
US1398
Shreveport, Louisiana, United States
US1404
Shreveport, Louisiana, United States
US1086
Flowood, Mississippi, United States
US1444
Las Vegas, Nevada, United States
US1426
Berlin, New Jersey, United States
US1454
Marlton, New Jersey, United States
US1405
Glen Oaks, New York, United States
US1244
Jamaica, New York, United States
US1394
New York, New York, United States
US1416
New York, New York, United States
US1171
Rochester, New York, United States
US1190
Staten Island, New York, United States
US1390
Charlotte, North Carolina, United States
US1401
Charlotte, North Carolina, United States
US1441
Hickory, North Carolina, United States
US1124
Norristown, Pennsylvania, United States
US1319
Charleston, South Carolina, United States
US1451
Austin, Texas, United States
US1065
Dallas, Texas, United States
US1443
Fort Worth, Texas, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-003569-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16159A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.